MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-27 for PROLENE BLUE 1.0M 90CM W/NDL W8556 manufactured by Ethicon Inc..
[188521836]
(b)(4). Attempts are being made to receive a device for evaluation. To date the device has not been returned yet. If the device or further details are received at the later date a supplemental medwatch will be sent.
Patient Sequence No: 1, Text Type: N, H10
[188521837]
It was reported that the patient underwent a liver transplant surgery on (b)(6) 2020 and the suture was used. The needle and thread separated during procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-02442 |
| MDR Report Key | 9892255 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-03-27 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | ETHICON INC.-SAN LORENZO PR |
| Manufacturer Street | PUITS-GODET 20 |
| Manufacturer City | SAN LORENZO PR |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROLENE BLUE 1.0M 90CM W/NDL |
| Generic Name | SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE |
| Product Code | GAW |
| Date Received | 2020-03-27 |
| Catalog Number | W8556 |
| Lot Number | PJR699 |
| 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 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |