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 ABSORBABLE SURGICAL SUTURE NW2763 manufactured by Ethicon Inc..
[188258729]
Product complaint (b)(4). Batch manufacturing records was reviewed for any process deviation but no deviation was observed. Attempts were made to obtain 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. What is the name of the procedure? What was used to complete the procedure? What is the current condition of the patient? What tissue was being approximated or sutured when it broke? Could you please confirm if we will receive the device? Product return status indicates availability unknown.
Patient Sequence No: 1, Text Type: N, H10
[188258730]
It was reported that the patient underwent an unknown procedure on 3/1/2020 and the suture was used. During the procedure when surgeon pull suture for making knot, the suture break. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-02438 |
| MDR Report Key | 9891982 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-03-01 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-04-01 |
| 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.-AURANGABAD INDIA |
| Manufacturer Street | 312379@B-15/1, M.I.D.C., 1 WALU |
| Manufacturer City | AURANGABAD |
| Manufacturer Country | IN |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABSORBABLE SURGICAL SUTURE |
| Generic Name | SUTURE, ABSORBABLE, SYNTHETIC |
| Product Code | GAM |
| Date Received | 2020-03-27 |
| Catalog Number | NW2763 |
| Lot Number | T9001 |
| 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 |