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 2020-03-30 for PDSII VIO 27IN 4-0 S/A BB D8350 manufactured by Ethicon Inc..
[185744655]
(b)(4). A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified. Attempts are being made to receive a device for evaluation. To date the device has not been returned. If the device or further details are received at the later date a supplemental medwatch will be sent. Additional information was requested, and the following was obtained: was the surgery completed successfully? No further information is available. What is the current condition of the patient? No further information is available. What was used to complete the procedure? No further information is available. How many of the total quantity were actually involved for the reported issue? No further information is available. 2nd device return follow up. We regularly contact with sales rep about the device returning. No further information will be provided.
Patient Sequence No: 1, Text Type: N, H10
[185744656]
It was reported that the patient underwent an unknown chest/thoracic surgery on (b)(6) 2020 and the suture was used. During the procedure, the suture was broken during use in the thoracic cavity. There were no patient consequences reported. No further information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-02452 |
| MDR Report Key | 9900297 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2019-07-29 |
| Date Added to Maude | 2020-03-30 |
| 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 4-0 S/A BB |
| Generic Name | SUTURE, SURGICAL, ABSORBABLE |
| Product Code | NEW |
| Date Received | 2020-03-30 |
| Model Number | D8350 |
| Catalog Number | D8350 |
| Lot Number | PHK651 |
| 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 | 2020-03-30 |