MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-05-04 for HOLLISTER * manufactured by Hollister, Inc..
[388244]
Plastibell circumcision device caused laceration to glans of penis and the device had to be removed. The device initially has a bell shaped piece of plastic on it that is snapped off after the circumcision is done leaving a plastic ring on the penis that normally falls off in a few days. Left 2 sharp edges on it that caused the laceration. Rptr still has the device in a container. Over the years rptr has had to remove a few of these for the same reason. First time rptr has reported.
Patient Sequence No: 1, Text Type: D, B5
[412766]
The agency informed hollister that the initial reporter requested that their name and info be held as confidential and was not to be given to the mfr. As a result hollister was unable to investigate the report with the initial reporter. Hollister's investigation regarding report # mw1035412 was limited to a review of the mfg records for the identified lot number. The results of the lot investigation indicated that the product was produced per the appropriate product specification. Hollister will continue to monitor the product performance of the plastibell circumcision device for adverse trends per hollister's standard product monitoring procedures.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1035412 |
| MDR Report Key | 601299 |
| Date Received | 2005-05-04 |
| Date of Report | 2005-05-04 |
| Date of Event | 2005-03-15 |
| Date Added to Maude | 2005-05-12 |
| 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 | PLASTIBELL CIRCUMCISION DEVICE |
| Product Code | FHG |
| Date Received | 2005-05-04 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 3K07 |
| ID Number | * |
| Device Expiration Date | 2008-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 591125 |
| Manufacturer | HOLLISTER, INC. |
| Manufacturer Address | * LIBERTYVILLE IL 60048 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-05-04 |