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 2020-03-18 for PDSII VIO 27IN USP0 Z2017H manufactured by Ethicon Inc..
[184649856]
(b)(4). A manufacturing record evaluation was performed for the finished device lot pc6763, and no non-conformances were identified. Attempts have been made to retrieve the device. 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. Additional information was requested and the following was obtained: specific number of sutures that failed in this single procedure? According the initial declaration, 3 sutures failed during one digestive procedure. When did the issue occur for each device, before use on patient or during actual use on the patient? According the initial declaration, 3 sutures failed during one digestive procedure. How was case completed? Use of another device from another box to complete the procedure. No patient consequence. Note: events reported in 2210968-2020-02199, and 2210968-2020-02201.
Patient Sequence No: 1, Text Type: N, H10
[184649857]
It was reported that a patient underwent a digestive surgery on an unknown date and suture was used. During the procedure, the suture pulled off the needle. Another like device was used to complete the procedure with no adverse patient consequences. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-02200 |
| MDR Report Key | 9848647 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-18 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2019-03-19 |
| Date Added to Maude | 2020-03-18 |
| 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 | CUIDAD 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 USP0 |
| Generic Name | SUTURE, SURGICAL, ABSORBABLE |
| Product Code | NEW |
| Date Received | 2020-03-18 |
| Catalog Number | Z2017H |
| Lot Number | PC6763 |
| 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 | 2020-03-18 |