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 2018-01-10 for NYLON SUTURE UNKNOWN PRODUCT manufactured by Ethicon Inc..
[96850781]
(b)(4). 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? Lot#? Procedure name? Any patient consequences / ae report? Was the procedure completed successfully? And how?
Patient Sequence No: 1, Text Type: N, H10
[96850782]
It was reported that during an unknown procedure on (b)(6) 2017, suture was used. It was reported that the needle detached from the thread without exerting any force. There was a risk of falling into the patient's mouth. There were no patient consequences. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2018-70175 |
| MDR Report Key | 7178519 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-01-10 |
| Date of Report | 2017-12-12 |
| Date of Event | 2017-12-07 |
| Date Mfgr Received | 2017-12-12 |
| Date Added to Maude | 2018-01-10 |
| 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 | NYLON SUTURE UNKNOWN PRODUCT |
| Generic Name | SUTURE, NON-ABSORBABLE |
| Product Code | GAO |
| Date Received | 2018-01-10 |
| Catalog Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-01-10 |