MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-01 for PERMA SOFT DENTURE RE LINER KIT manufactured by Perma Laboratories.
[81774416]
I had a very bad allergic reaction from "perma soft" denture re liner kit. Within 2 minutes of having it in my mouth, it started to burn so i took it out. Within a few seconds, the back of my tongue started swelling and i was having a hard time swallowing and i could not breathe. Thank god my husband got home in time to rush me to the er. I was immediately treated with iv steroids, iv benadryl and a breathing treatment. Sent home with rx of 60 mg prednisone per day for 5 days. I have moderate asthma and i have used this product before with no complications. There is just a vague warning on the insert paper that states "do not use if allergic to methacrylates. " now, "how many people know what that is. " it should have a warning directed to asthmatics who may be more likely to have a reaction or take it off the market. I could have died, luckily the er is just 3 blocks from my home. Dates of use: (b)(6) 2017. Reason for use: to reline denture.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5071340 |
| MDR Report Key | 6760495 |
| Date Received | 2017-08-01 |
| Date of Report | 2017-07-31 |
| Date of Event | 2017-07-29 |
| Date Added to Maude | 2017-08-02 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PERMA SOFT DENTURE RE LINER KIT |
| Generic Name | RELINER DENTURE, OTC |
| Product Code | EBP |
| Date Received | 2017-08-01 |
| Lot Number | 0970-14BB |
| Device Expiration Date | 2015-10-30 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | PERMA LABORATORIES |
| Brand Name | PERMA SOFT DENTURE RE LINER KIT |
| Generic Name | RELINER DENTURE, OTC |
| Product Code | EBP |
| Date Received | 2017-08-01 |
| Lot Number | 0970-14BB |
| Device Expiration Date | 2015-10-30 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PERMA LABS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2017-08-01 |