FDA Adverse Event
Malfunction
Summary report: N
1.1 DISPOSABLE GOMCO
MDR report key: 957517
·
Received April 30, 2007
Report
- Report Number
- 1282497-2007-00011
- Event Type
- Malfunction
- Date Received
- April 30, 2007
- Date of Event
- April 25, 2007
- Report Date
- April 26, 2007
- Manufacturer
- TYCO HEALTHCARE/KENDALL
- Product Code
- FHG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO TYCO HEALTHCARE/KENDAL ON 04/26/2007 THAT THE PHYSICIAN WAS REMOVING THE CLAMP BY UNSCREWING IT. THE SCREW SUDDENLY 'POPPED OFF' (AFTER ONLY ONE ROTATION) AND CUT THE BABY. THERE WAS A SMALL ABRASION RIGHT UNDER THE GLAND. THEY APPLIED PRESSURE FOR 2 MINS TO STOP THE BLEEDING. STILL WOULD NOT STOP. THEY USED SILVER NITRATE TO STOP THE BLEEDING AND WRAPPED THE WOUND. THE BABY WAS DISCHARGED THE SAME DAY. PHYSICIAN WHO PERFORMED THE CIRCUMCISION HAS FOLLOWED UP WITH THE PARENTS OF THE BABY; BABY IS DOING FINE, ALTHOUGH STILL SWOLLEN. BABY IS URINATING NORMALLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 1.1 DISPOSABLE GOMCO | CIRCUMCISION DEVICE | FHG | TYCO HEALTHCARE/KENDALL | 56421 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |