MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2003-07-18 for PLASTIBELL CIRCUMCISION DEVICE * UNK manufactured by Hollister, Inc..
[301264]
It was alleged that during a circumcision procedure where a plastibell was used there was a severing of the pt's urethra and a slicing of the pt's "gland".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1921454-2003-00001 |
| MDR Report Key | 473788 |
| Report Source | 00 |
| Date Received | 2003-07-18 |
| Date of Report | 2003-07-14 |
| Date of Event | 2002-03-04 |
| Date Mfgr Received | 2003-06-09 |
| Date Added to Maude | 2003-07-29 |
| 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 |
| Reporter Occupation | ATTORNEY |
| 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 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLASTIBELL CIRCUMCISION DEVICE |
| Generic Name | CIRCUMCISION DEVICE |
| Product Code | FHG |
| Date Received | 2003-07-18 |
| Model Number | * |
| Catalog Number | UNK |
| 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 | 462639 |
| Manufacturer | HOLLISTER, INC. |
| Manufacturer Address | 2000 HOLLISTER DRIVE LIBERTYVILLE IL 60048 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-07-18 |