MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-04-30 for 1.1 DISPOSABLE GOMCO 56421 manufactured by Tyco Healthcare/kendall.
[771917]
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.
Patient Sequence No: 1, Text Type: D, B5
[8119963]
An investigation is currently underway. Upon completion, results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1282497-2007-00011 |
| MDR Report Key | 957517 |
| Report Source | 05,06 |
| Date Received | 2007-04-30 |
| Date of Report | 2007-04-26 |
| Date of Event | 2007-04-25 |
| Date Facility Aware | 2007-04-25 |
| Report Date | 2007-04-26 |
| Date Reported to Mfgr | 2007-04-26 |
| Date Mfgr Received | 2007-04-26 |
| Date Added to Maude | 2007-12-05 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JENNIFER REED |
| Manufacturer Street | 15 HAMPSHIRE ST. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082616620 |
| Manufacturer G1 | TYCO HEALTHCARE/KENDALL |
| Manufacturer Street | FABRICA BLVD INSURGENTES LA MESA |
| Manufacturer City | TIJUANA |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 1.1 DISPOSABLE GOMCO |
| Generic Name | CIRCUMCISION DEVICE |
| Product Code | FHG |
| Date Received | 2007-04-30 |
| Model Number | 56421 |
| Catalog Number | 56421 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 927891 |
| Manufacturer | TYCO HEALTHCARE/KENDALL |
| Manufacturer Address | FABRICA BLVD INSURGENTES TIJUANA MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-04-30 |