MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-25 for GOMCO 28-854 manufactured by Fine Surgical Instruments, Inc..
[121917760]
Physician performed circumcision. During the procedure, the top piece of the bell that rests on the gomco broke off. Physician finished the procedure without difficulty; no harm to patient or abnormal bleeding. After procedure, routine care was given and patient taken to mother. Pt discharged w/o complications related to circumcision.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080117 |
| MDR Report Key | 7910357 |
| Date Received | 2018-09-25 |
| Date of Report | 2018-09-07 |
| Date of Event | 2018-07-13 |
| Date Added to Maude | 2018-09-26 |
| 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 | 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 |
| Generic Name | CIRCUMCISION CLAMP 1.1 CM |
| Product Code | HFX |
| Date Received | 2018-09-25 |
| Catalog Number | 28-854 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FINE SURGICAL INSTRUMENTS, INC. |
| Manufacturer Address | HEMPSTEAD NY 11550 US 11550 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-25 |