MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-29 for STLESS STEEL SIL 4X18IN 7 S/A CCS M655G manufactured by Ethicon Inc..
[177188818]
(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.
Patient Sequence No: 1, Text Type: N, H10
[177188819]
It was reported that the patient underwent an open-heart surgery on (b)(6) 2020 and the suture was used. When the surgeon was twisting the steel suture, it broke. The procedure was completed with another like device with no patient consequences reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-00821 |
| MDR Report Key | 9645052 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-29 |
| Date of Report | 2020-01-13 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2019-09-11 |
| Date Added to Maude | 2020-01-29 |
| 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 | 982 ROAD 183 KM 8.3 |
| Manufacturer City | SAN LORENZO PR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STLESS STEEL SIL 4X18IN 7 S/A CCS |
| Generic Name | SUTURE, NONABSORBABLE, STEEL |
| Product Code | GAQ |
| Date Received | 2020-01-29 |
| Model Number | M655G |
| Catalog Number | M655G |
| Lot Number | PKR595 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-01-29 |