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 2020-03-31 for NON ABSORBABLE SURGICAL SUTURE NW825 manufactured by Ethicon Inc..
[188522388]
(b)(4). 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 attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. Please verify specific quantity involved in the this single procedure. Lot number. Any adverse patient consequences and what medical/surgical intervention was provided to manage them? How was case completed? Device return status.
Patient Sequence No: 1, Text Type: N, H10
[188522389]
It was reported that the patient underwent an anima hernia repair surgery on (b)(6) 2020 and the suture was used. During the procedure, the suture broke while knotting. The procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-02486 |
| MDR Report Key | 9904152 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2020-03-31 |
| 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. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NON ABSORBABLE SURGICAL SUTURE |
| Generic Name | SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE |
| Product Code | GAW |
| Date Received | 2020-03-31 |
| Catalog Number | NW825 |
| 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 | 2020-03-31 |