MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2014-09-09 for ETHICON COTTON UMBILICAL TAPE UNK U11T manufactured by Ethicon Inc..
[4747397]
It was reported that a patient underwent an unknown procedure on an unknown date and cotton umbilical tape was used. The product was cut in half. The surgeon was unable to locate one half of the product and was not certain whether the product was retained in the patient.
Patient Sequence No: 1, Text Type: D, B5
[12188726]
(b)(4). No conclusion can be drawn at this time. Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2210968-2014-12513 |
| MDR Report Key | 4074564 |
| Report Source | * |
| Date Received | 2014-09-09 |
| Date of Report | 2014-08-14 |
| Date Mfgr Received | 2014-08-13 |
| Date Added to Maude | 2014-09-09 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | GUILLERMO VILLA |
| Manufacturer Street | ROUTE 22 WEST PO BOX 151 |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9082180707 |
| Manufacturer G1 | ETHICON INC.-JUAREZ |
| Manufacturer Street | AVENIDA DE LAS TORRES 7125, CO L SALVACAR |
| Manufacturer City | CIUDAD JUAREZ 32604 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 32604 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ETHICON COTTON UMBILICAL TAPE |
| Product Code | GAO |
| Date Received | 2014-09-09 |
| Model Number | UNK |
| Catalog Number | U11T |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON INC. |
| Manufacturer Address | P.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 08876015 US 08876 0151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-09-09 |