MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-28 for GEL FOAM manufactured by .
[24998847]
I was recently diagnosed with "arachnoiditis". My orthopedic surgeon used "gel foam" during the surgery which caused permanent nerve damage and chronic pain in my spine since having surgery in 1999. I am unable to perform everyday duties in my life.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5055917 |
| MDR Report Key | 5053995 |
| Date Received | 2015-08-28 |
| Date of Report | 2015-08-28 |
| Date of Event | 1999-01-01 |
| Date Added to Maude | 2015-09-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | GEL FOAM |
| Generic Name | GEL FOAM |
| Product Code | FQL |
| Date Received | 2015-08-28 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2015-08-28 |