MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-13 for ETHILON BLK 45CM M0.7::USP6/0 SGLE ARMED PS-3 PRIM MP XAMPE7662H manufactured by Ethicon Inc..
[188073388]
(b)(4). A manufacturing record evaluation was performed for the finished device lot number peb903-xampe7662, and no non-conformances were identified. The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete. Any further information derived from the evaluation will be submitted in a supplemental 3500a form. Additional information was requested and the following was obtained: was the reported device issue related to needle pull off or suture breakage? Suture breakage. When did the event occurred; during dispensing or during use on patient? During the use. Were there any unexpected outcomes or complications as a result of the prolonged surgery time? No. Was the patient treatment altered in anyway due to the prolonged surgery time? If yes, please explain no. How many devices were involved in this single procedure? 3. Patient? S current status? Doing well. 4 device returned and events reported in 2210968-2020-02023, 2210968-2020-02024, 2210968-2020-02025.
Patient Sequence No: 1, Text Type: N, H10
[188073389]
It was reported that the patient underwent a dental procedure in 2020 and suture was used. During the procedure, the thread broke at the leaving of the shuttle. The device is too fragile. Use of another device to complete the procedure with 30 minute delay. There were no adverse patient consequences reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-02026 |
| MDR Report Key | 9829483 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-13 |
| Date of Report | 2020-02-19 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2019-05-02 |
| Date Added to Maude | 2020-03-13 |
| 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.-SAN LORENZO PR |
| Manufacturer Street | ROAD 183, KM. 8.3 |
| Manufacturer City | SAN LORENZO 00754 |
| Manufacturer Country | * |
| Manufacturer Postal Code | 00754 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ETHILON BLK 45CM M0.7::USP6/0 SGLE ARMED PS-3 PRIM MP |
| Generic Name | SUTURE, NONABSORBABLE, SYNTHETIC |
| Product Code | GAR |
| Date Received | 2020-03-13 |
| Returned To Mfg | 2020-03-11 |
| Catalog Number | XAMPE7662H |
| Lot Number | PEB903 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-13 |