MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-25 for PDSII VIO 27IN 3-0 S/A FS-1 Z452G manufactured by Ethicon Inc..
[188517512]
(b)(4). A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified. To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent.
Patient Sequence No: 1, Text Type: N, H10
[188517513]
It was reported that a patient underwent an unknown procedure on (b)(6) 2020 and the suture was used. During surgery, the suture kept breaking. Upon inspecting the suture later on, small weak spots were noticed along the whole length of the suture. A like device was used to complete the procedure. There were no adverse patient consequences reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-02335 |
| MDR Report Key | 9876354 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-25 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-02-27 |
| Date Mfgr Received | 2020-02-28 |
| Date Added to Maude | 2020-03-25 |
| 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.-JUAREZ |
| Manufacturer Street | AVENIDA DE LAS TORRES 7125 COL SALVACAR |
| Manufacturer City | CIUDAD JUAREZ 32604 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 32604 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PDSII VIO 27IN 3-0 S/A FS-1 |
| Generic Name | SUTURE, SURGICAL, ABSORBABLE |
| Product Code | NEW |
| Date Received | 2020-03-25 |
| Model Number | Z452G |
| Catalog Number | Z452G |
| Lot Number | PCM661 |
| 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 | 2020-03-25 |