MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-12 for SUTURE UNKNOWN manufactured by Ethicon Inc..
[62388835]
(b)(4). To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent. Additional information was requested and the following was obtained: did the operating surgeon observe any suture deficiency or anomaly before, during or after its use in the patient: during its use. Did any piece of the needle fall inside of the patient? If so, was the needle piece removed and how: no. When did the needle pull off (while in the package / during dispensing / during preparation / during use): during its use. Can you identify the product code and lot number of the device used: no. Are there any samples available to be returned for evaluation: no.
Patient Sequence No: 1, Text Type: N, H10
[62388836]
It was reported that the patient underwent gastroplasty procedure on (b)(6) 2016 and suture was used. During the procedure, the needle pulled off from the suture. Another like device was used to complete the procedure. There were no adverse consequences for the patient reported. No additional information will be provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2016-15411 |
| MDR Report Key | 6166130 |
| Date Received | 2016-12-12 |
| Date of Report | 2016-11-24 |
| Date of Event | 2016-11-23 |
| Date Mfgr Received | 2016-11-23 |
| Date Added to Maude | 2016-12-12 |
| 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 | KRYSTINA LAGUNA |
| Manufacturer Street | ROUTE 22 WESTP O BOX 151 |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9082183043 |
| Manufacturer G1 | UNKNOWN |
| Manufacturer Street | UNKNOWN |
| Manufacturer City | X |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SUTURE UNKNOWN |
| Product Code | GAO |
| Date Received | 2016-12-12 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| 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 088760151 US 088760151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-12 |