MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-08-06 for * manufactured by Unk.
[19158913]
Doctor failed to check compatability of gomco clamp parts. Once started procedure, the clamp fell apart resulting in the procedure not complete. Only half of the foreskin had been cut and none of the foreskin sealed. The pt was rushed to a different hospital. There they were put under. The doctor finished the cut, sewed the skin all the way around their penis. Pt is now 3 years old and has about 40% extra skin much on the underneath side of their penis. I submitted a medical malpractice claim against the doctor for not checking the clamp and it was denied. If pt has any problems in the future pt is already asking what is wrong with their penis at the age of 3. Pt will have to foot the bill. The government denies any negligence in the procedure even though the doctor should have checked the parts. The doctor was not held accountable. Parent has also looked for a lawyer and cannot predict the future of pt's emotional state or its functionability -sexual feeling-, so it is not cost effective to take the case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1029234 |
| MDR Report Key | 477736 |
| Date Received | 2003-08-06 |
| Date of Report | 2003-08-06 |
| Date of Event | 2003-04-20 |
| Date Added to Maude | 2003-08-18 |
| 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 | 0 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| 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 | * |
| Generic Name | GOMCO CLAMP |
| Product Code | FHA |
| Date Received | 2003-08-06 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 466542 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK * UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2003-08-06 |