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 2017-09-15 for SUTURE UNKNOWN manufactured by Ethicon Inc..
[86447882]
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 the later date a supplemental medwatch will be sent.
Patient Sequence No: 1, Text Type: N, H10
[86447883]
It was reported that the patient underwent an unknown procedure in 2017 and unknown suture was used. During the procedure, the needle fell off and when the surgeon attempted to tie a knot the suture would break. It is unknown how the procedure was completed. There were no patient consequences reported. No further information is available.
Patient Sequence No: 1, Text Type: D, B5
[106043297]
Date send to the fda: 10/17/2017.
Patient Sequence No: 1, Text Type: N, H10
[106043298]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2017-70289 |
| MDR Report Key | 6868499 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-09-15 |
| Date of Report | 2017-08-22 |
| Date Mfgr Received | 2017-10-17 |
| Date Added to Maude | 2017-09-15 |
| 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 | DARLENE KYLE |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal | 088760151 |
| Manufacturer Phone | 9082182792 |
| Manufacturer G1 | ETHICON INC. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUTURE UNKNOWN |
| Generic Name | SUTURE, NONABSORBABLE |
| Product Code | GAO |
| Date Received | 2017-09-15 |
| Catalog Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON INC. |
| Manufacturer Address | P.O. BOX 151, ROUTE 22 WEST SOMERVILLE 088760151 US 088760151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-15 |