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 2019-11-25 for SUTURE UNKNOWN SUTUREUNK manufactured by Ethicon Inc..
[176821111]
(b)(4). 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. Product code and lot #? Any patient consequences as a result of event report? Was procedure completed successfully? Please confirm the specific number of patient events?
Patient Sequence No: 1, Text Type: N, H10
[176821112]
I would like to report two incidences where a needle has become completely detached from the suture material. In both instances, one which happened today and also once last week, the suture had been passed through the tissue and then became detached, leaving the suture material in the tissue of the patient and the needle separate in the needle holder. Obviously this is very unsatisfactory, and felt it needed to be reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2019-90305 |
| MDR Report Key | 9373849 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-11-25 |
| Date of Report | 2019-11-07 |
| Date of Event | 2019-01-01 |
| Date Mfgr Received | 2019-11-07 |
| Date Added to Maude | 2019-11-25 |
| 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 | SUTURE UNKNOWN |
| Generic Name | SUTURE, NONABSORBABLE |
| Product Code | GAO |
| Date Received | 2019-11-25 |
| Catalog Number | SUTUREUNK |
| 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 | 2019-11-25 |