MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-02-26 for 7381 GOMCO DELUXE 1.1 52000031 manufactured by Covidien.
[1139381]
It was reported to covidien on 02/09/2009 that a customer had a problem with a gomco. The customer reports upon tightening the 1. 1 gomco, the doctor experienced cutting of the foreskin of the penis without using the blade. The gomco itself cut the foreskin and the infant received a cut that required sutures.
Patient Sequence No: 1, Text Type: D, B5
[8143587]
(b) (4). An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1282497-2009-00008 |
| MDR Report Key | 1379522 |
| Report Source | 06 |
| Date Received | 2009-02-26 |
| Date of Report | 2009-02-09 |
| Date of Event | 2009-01-05 |
| Report Date | 2009-02-09 |
| Date Reported to Mfgr | 2009-02-09 |
| Date Mfgr Received | 2009-02-09 |
| Date Added to Maude | 2010-01-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | JANICE NEVIUS |
| Manufacturer Street | 15 HAMPSHIRE ST. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082616283 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 37 BLVD. INSURGENTES LIBRIAMENTO |
| Manufacturer City | LA MESA, TIJUANA |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 7381 GOMCO DELUXE 1.1 |
| Generic Name | GOMCO |
| Product Code | FHG |
| Date Received | 2009-02-26 |
| Model Number | 52000031 |
| Catalog Number | 52000031 |
| Lot Number | 8294079 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 37 BLVD. INSURGENTES LIBRIAMENTO TIJUANA MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-02-26 |