MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-03-26 for 1.1 DISPOSABLE GOMCO 56421 manufactured by Nellcor.
[20888340]
It was reported to tyco health care/kendall in 2008, that a customer had a problem with a circumcision device. Customer stated that later in the day, after the circumcision procedure, blood was noted in the infant's diaper.
Patient Sequence No: 1, Text Type: D, B5
[21198823]
On 18 mar 2008, i spoke with customer risk management who stated: " infant had no known clotting problems, avitene was used bleeding stopped. " an investigation is currently under way. Upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1282497-2008-00008 |
| MDR Report Key | 1023690 |
| Report Source | 05,06 |
| Date Received | 2008-03-26 |
| Date of Report | 2008-03-18 |
| Report Date | 2008-03-18 |
| Date Reported to FDA | 2008-02-20 |
| Date Reported to Mfgr | 2008-03-18 |
| Date Mfgr Received | 2008-03-18 |
| Date Added to Maude | 2008-09-17 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | LAURA MILES |
| Manufacturer Street | 15 HAMPSHIRE ST. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082616620 |
| Manufacturer G1 | NELLCOR |
| Manufacturer Street | FABRICA BLVD INSURGENTES |
| Manufacturer City | LA MESA, TIJUANA |
| Manufacturer Country | MX |
| Single Use | 0 |
| 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 | 2008-03-26 |
| Model Number | 56421 |
| Catalog Number | 56421 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1021304 |
| Manufacturer | NELLCOR |
| Manufacturer Address | FABRICA BLVD INSURGENTES TIJUANA MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-03-26 |