MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-04 for GOMCO manufactured by Unknown.
[93590924]
Patient Sequence No: 1, Text Type: N, H10
[93590925]
During circumcision, two gomco sets were opened. Both were a 1. 1cm gomco, but a 1. 3cm bell was inside one of them. Doctor used the 1. 3cm bell but when she attempted to apply the clamp, it would not allow her to screw the top on (it did not fit). It was then that it was discovered that the bell and the clamp were two different sizes. The clamp had to be removed and an additional circumcision set was opened to get the right size clamp. There was increased bleeding with the circumcision, unsure if related to increased manipulation or anatomic factors.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7078676 |
| MDR Report Key | 7078676 |
| Date Received | 2017-12-04 |
| Date of Report | 2017-11-21 |
| Date of Event | 2017-11-20 |
| Report Date | 2017-11-21 |
| Date Reported to FDA | 2017-11-21 |
| Date Reported to Mfgr | 2017-11-21 |
| Date Added to Maude | 2017-12-04 |
| 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 | 3 |
| Brand Name | GOMCO |
| Generic Name | CLAMP, CIRCUMCISION |
| Product Code | HFX |
| Date Received | 2017-12-04 |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-04 |