MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-18 for GOMCO DEVICE FOR CIRCUMCISION 1.1 CLAMP manufactured by .
[124555379]
Physician was doing a circumcision using the gomco device with a 1. 1 clamp. As the procedure was completed they noted bleeding from the side of the baby's penis. Pressure was applied, followed by silver nitrate and eventually stitches were required to stop the bleeding. Upon close inspection of the gomco device, it was noted that the "bell" had a sharp edge. We don't have a method to track how old the device might have been or how many times it has been used and reprocessed. As a result, two gomco devices with 1. 1 clamps were taken out of service to avoid this from happening again.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7981789 |
| MDR Report Key | 7981789 |
| Date Received | 2018-10-18 |
| Date of Report | 2018-10-02 |
| Date of Event | 2018-07-25 |
| Report Date | 2018-10-02 |
| Date Reported to FDA | 2018-10-02 |
| Date Reported to Mfgr | 2018-10-18 |
| Date Added to Maude | 2018-10-18 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 DEVICE FOR CIRCUMCISION 1.1 CLAMP |
| Generic Name | CLAMP, CIRCUMCISION |
| Product Code | HFX |
| Date Received | 2018-10-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-18 |