MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-05-03 for HOLLISTER 3605 manufactured by Hollister.
[397041]
Rhizopus mold infection post ostomy surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1035378 |
| MDR Report Key | 600067 |
| Date Received | 2005-05-03 |
| Date of Report | 2005-04-21 |
| Date of Event | 2005-02-13 |
| Date Added to Maude | 2005-05-10 |
| 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 | 3 |
| 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 | HOLLISTER |
| Generic Name | 2 1/2" KARAYA 5 WITH DRAINABLE BAG |
| Product Code | FON |
| Date Received | 2005-05-03 |
| Model Number | 3605 |
| Catalog Number | 3605 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 589904 |
| Manufacturer | HOLLISTER |
| Manufacturer Address | * LIBERTYVILLE IL * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2005-05-03 |