MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2002-10-29 for HOLLISTER PLASTIBELL 9212 * manufactured by Hollister, Incorporated.
[266877]
During routine circumcision the device caused irritation and bleeding possibly the result of excessive rough edges remaining after preparing the device for use by removing the "handle".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1921454-2002-00003 |
| MDR Report Key | 425655 |
| Report Source | 06 |
| Date Received | 2002-10-29 |
| Date of Report | 2002-09-09 |
| Date of Event | 2002-09-02 |
| Date Mfgr Received | 2002-09-09 |
| Date Added to Maude | 2002-11-05 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 2000 HOLLISTER DRIVE |
| Manufacturer City | LIBERTYVILLE IL 60048 |
| Manufacturer Country | US |
| Manufacturer Postal | 60048 |
| Manufacturer Phone | 8476802849 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOLLISTER PLASTIBELL |
| Generic Name | CIRCUMSION DEVICE |
| Product Code | FHG |
| Date Received | 2002-10-29 |
| Model Number | 9212 |
| Catalog Number | * |
| Lot Number | 2A01A |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 414706 |
| Manufacturer | HOLLISTER, INCORPORATED |
| Manufacturer Address | 2000 HOLLISTER DRIVE LIBERTYVILLE IL 60048 US |
| Baseline Brand Name | HOLLISTER PLASTIBELL |
| Baseline Generic Name | CIRCUMSION DEVICE |
| Baseline Model No | 9212 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2002-10-29 |