MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-24 for GOMCO USA manufactured by .
[143540871]
Pt presented to nursery for elective circumcision. Clamp was tested prior to procedure and felt to be working properly. Excessive bleeding noted after procedure due to defective clamp which failed to seal the skin edges. Pt required 2 sutures to achieve hemostasis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8561658 |
| MDR Report Key | 8561658 |
| Date Received | 2019-04-24 |
| Date of Report | 2019-04-15 |
| Date of Event | 2019-04-12 |
| Date Facility Aware | 2019-04-15 |
| Report Date | 2019-04-15 |
| Date Added to Maude | 2019-04-29 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GOMCO USA |
| Generic Name | CIRCUMCISION KIT |
| Product Code | OHG |
| Date Received | 2019-04-24 |
| Lot Number | PAT 1972-3392728 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 15 YR |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-24 |