MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-10-09 for GOMCO CIRCUMCISION CLAMP * manufactured by Tri-state Hospital Supply Corporation.
[713637]
During circumcision, physician stated that the gomco was defective because she could not get instrument to clamp down good. After circumcision, physician noted bleeding at site. Several silver nitrate sticks were used by physician and bleeding stopped. Baby was monitored for bleeding after circumcision and no further bleeding noted. When examined, washer was found on gomco, but underneath the main part instead of next to the screw used to clamp the instrument. All parts were present. The washer is supposed to be on the top next to the screw when it goes for sterilization. When the instrument is given to the doctor, he/she can change it if they choose to. The washer did not break. No other device identifiers are available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 938685 |
| MDR Report Key | 938685 |
| Date Received | 2007-10-09 |
| Date of Report | 2007-09-07 |
| Date of Event | 2007-04-18 |
| Report Date | 2007-09-07 |
| Date Reported to FDA | 2007-10-09 |
| Date Added to Maude | 2007-11-07 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GOMCO CIRCUMCISION CLAMP |
| Generic Name | CIRCUMCISION CLAMP |
| Product Code | FHG |
| Date Received | 2007-10-09 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 910809 |
| Manufacturer | TRI-STATE HOSPITAL SUPPLY CORPORATION |
| Manufacturer Address | 301 CATRELL DRIVE P.O. BOX 170 HOWELL MI 48843 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-10-09 |