Adamis Pharmaceuticals Corp (ADMP)

[66Mustang]

Anybody can poke themselves with a needle by ignoring the instructions and/or being generally careless. That is true fir ZIMHI, COVID vaccines, and sewing, among numerous other activities which use needles.

The instructions very clearly state how to operate the device safely and how to deploy the safety sheath in a safe manner. I do not want to receive medical care from someone who is incapable of following these very clear and simple instructions.

Part of the FDA approval process and review and acceptance of safety criteria, and their approval of this product (and our Symjepi product which uses a very similar device) shows what the FDA's opinion is with regard to safety of this device.

Next, someone should complain to the FDA that the device is an eye hazard because it doesn't say "Do not push the device into your eyeball."

It does, however, say:

"'- Never put thumb, fingers, or hand over the exposed needle. Failure to follow these instructions may result in a
needlestick injury"

It also says:
"Right after the injection, using one hand with fingers behind the
needle, slide the safety guard over the needle."

And, similarly, as you noted below:
"'- Immediately after injection, using one hand with fingers behind the needle, slide the safety guard over the needle. Do not
use two hands to activate the safety guard.'"

Don't forget:
"Stress to patients the importance of familiarizing themselves with the device and its operation prior to experiencing an emergency situation."

If the user (medical professional or not) follows the simple instructions, the only needle contact is the intentional and necessary needle contact with the PATIENT ONLY.

I believe your "evidence" is a gross and blatant misinterpretation of the facts to try to besmirch the product, the company, and me. I again ask that others review all the information in this post, yours and mine, and judge for themselves.


Message in reply to:
Post 3501 " No needle contact by medical personnel." This is not true as per the FDA document provided. You asked for evidence and I give you the FDA.

Also, if this is to be used my non medical professionals so the concerns I have laid out are valid and backed by this document. This has been completely ignored.


Information below was pulled from link at bottom of post which is instructions on Zimhi.

'Risk of Accidental Needlestick Injury: After use, the ZIMHI needle is exposed until the safety guard is deployed. Stress to patients the importance of familiarizing themselves with the device and its operation prior to experiencing an emergency situation, and to immediately seek medical attention should a needlestick occur.'

'- Embed the needle completely before transferring the thumb to the syringe plunger.'

'- Immediately after injection, using one hand with fingers behind the needle, slide the safety guard over the needle. Do not
use two hands to activate the safety guard.'

'- Never put thumb, fingers, or hand over the exposed needle. Failure to follow these instructions may result in a
needlestick injury. If an accidental needlestick occurs, get medical help immediately [see Warnings and Precautions
(5.4)].'

'- Do NOT attempt to re-cap the needle with the needle cap once it has been removed [see Warnings and Precautions
(5.4)].'

https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212854s000lbl.pdf#:~:text=%285.3%29%20%E2%80%A2%20Risk%20of%20Accidental%20Needlestick%20Injury%3A%20After,seek%20medical%20attention%20should%20a%20needlestick%20occur.%20%285.4%29