MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2005-11-09 for HOLLISTER 3609 manufactured by Hollister, Inc..
[430070]
Rhizopus mold infection post ostomy surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119193-2005-00003 |
| MDR Report Key | 647066 |
| Report Source | 05,06 |
| Date Received | 2005-11-09 |
| Date of Report | 2005-04-21 |
| Date of Event | 2005-04-12 |
| Date Mfgr Received | 2005-05-17 |
| Date Added to Maude | 2005-11-23 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 2000 HOLLISTER DR. |
| Manufacturer City | LIBERTYVILLE IL 60048 |
| Manufacturer Country | US |
| Manufacturer Postal | 60048 |
| Manufacturer Phone | 8476802849 |
| Manufacturer G1 | HOLLISTER INC. |
| Manufacturer Street | 366 DRAFT AVE. |
| Manufacturer City | STUARTS DRAFT VA 24477999 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 24477 9998 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOLLISTER |
| Generic Name | 1 3/4" KARAYA 5 WITH DRAINABLE BAG |
| Product Code | FON |
| Date Received | 2005-11-09 |
| Model Number | 3609 |
| Catalog Number | 3609 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 636556 |
| Manufacturer | HOLLISTER, INC. |
| Manufacturer Address | * LIBERTYVILLE IL 60048 US |
| Baseline Brand Name | HOLLISTER |
| Baseline Generic Name | 1 3/4" KARAYA 5 WITH DRAINABLE BAG |
| Baseline Model No | 3609 |
| Baseline Catalog No | 3609 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2005-11-09 |