MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-11-13 for QUEST MEMBRANE OQ2530 manufactured by W L Gore & Associates.
[139703]
Several cases reviewed and common corrolation to this membrane which is causing an aggressive inflammatory response; sinus augmentation with bone graft causing nonclinical reaction. There was some tenderness that extended and became acute with severe granulation and destruction of tissue. Both of these pts had reoperation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1020376 |
| MDR Report Key | 304423 |
| Date Received | 2000-11-13 |
| Date of Report | 2000-11-13 |
| Date of Event | 2000-11-01 |
| Date Added to Maude | 2000-11-16 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUEST MEMBRANE |
| Generic Name | RESORBABLE MEMBRANE |
| Product Code | ESF |
| Date Received | 2000-11-13 |
| Model Number | NA |
| Catalog Number | OQ2530 |
| Lot Number | MULTIPLE |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | I |
| Device Sequence No | 1 |
| Device Event Key | 294602 |
| Manufacturer | W L GORE & ASSOCIATES |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-11-13 |