MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-05-14 for HOLLISTER * manufactured by *.
[16824602]
Pt had circumcision earlier in the day. When changing diaper found a moderate amount of bloody drainage from the circumcision site. Physician applied pressure but had difficulty controlling bleeding. Hollister plastibell removed. Finally controlled with silver nitrate. Hospitalization extended one day. Do not suspect long term effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1042883 |
| MDR Report Key | 852195 |
| Date Received | 2007-05-14 |
| Date of Report | 2007-05-14 |
| Date of Event | 2007-05-09 |
| Date Added to Maude | 2007-05-21 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOLLISTER |
| Generic Name | PLASTIBELL |
| Product Code | FHG |
| Date Received | 2007-05-14 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 838577 |
| Manufacturer | * |
| Manufacturer Address | 200 HOLLISTER DRIVE LIBERTYVILLE IL 60048 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2007-05-14 |