MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 1996-11-20 for TEGASORB UNK manufactured by 3m Medical Products.
[34597]
Elderly, black female admitted to nursing center on 8/16/95 with cancer of left breast, alzheimer's , arthritis, hypertension. On 9/4/95 a blister developed on pt's right upper groin area, burst, drained brown liquid while aide bathing. Dr on call ordered staff to cleanse wound with normal saline and apply dressing. On 9/6/95, nurse noted dressing started to come off. Dressing removed, nurse noted large open area about size of dressing. Dr requested to see pt next day. Dr admitted pt to care center and diagnosed with cellulitis and renal failure. Pt expired 9/11/95.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-1996-00008 |
| MDR Report Key | 51483 |
| Report Source | 04 |
| Date Received | 1996-11-20 |
| Date of Report | 1996-11-20 |
| Date of Event | 1995-09-04 |
| Date Facility Aware | 1995-09-04 |
| Report Date | 1996-11-20 |
| Date Reported to FDA | 1996-11-21 |
| Date Mfgr Received | 1996-11-12 |
| Date Added to Maude | 1996-11-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | ATTORNEY |
| 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 | 3 |
| Brand Name | TEGASORB |
| Generic Name | WOUND DRESSING |
| Product Code | MGP |
| Date Received | 1996-11-20 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 52153 |
| Manufacturer | 3M MEDICAL PRODUCTS |
| Manufacturer Address | 3M CENTER BLDG. 275-3E-08 ST. PAUL MN 551441000 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1996-11-20 |