MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-11-17 for GILT CIRCUMCISION TRAY * NL10-0064 manufactured by Cardinal Health.
[416546]
Physician was doing a circumcision. When the clamp was removed, it was noted to have amputated the distal tip of the penis. Tip was placed in saline and a urologist was called to evaluate the patient. The patient was taken immediately to the or where the penile tip was reattached.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 660121 |
| MDR Report Key | 660121 |
| Date Received | 2005-11-17 |
| Date of Report | 2005-11-15 |
| Date of Event | 2005-10-20 |
| Report Date | 2005-11-15 |
| Date Reported to FDA | 2005-11-17 |
| Date Added to Maude | 2006-01-07 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| 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 | GILT CIRCUMCISION TRAY |
| Generic Name | CIRCUMCISION KIT |
| Product Code | FHG |
| Date Received | 2005-11-17 |
| Model Number | * |
| Catalog Number | NL10-0064 |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 750512 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | 1430 WAUKEGAN ROAD MCGAW PARK IL 600856787 US |
| Baseline Brand Name | PRISMAFLEX SYSTEM |
| Baseline Generic Name | INTENSIVE CARE HEMODIALYSIS |
| Baseline Model No | 107493 |
| Baseline Catalog No | 107493 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2005-11-17 |