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 2020-03-24 for ETHILON*BLACK4-0 45CM (1)CP-25 15502T manufactured by Ethicon Inc..
[188516528]
(b)(4). Attempts have been made to retrieve the device. 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.
Patient Sequence No: 1, Text Type: N, H10
[188516529]
It was reported that a patient underwent an unknown procedure on (b)(6) 2020 and suture was used. During the procedure, the suture ruptured without applying extra tension. There were no adverse patient consequences reported. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-02318 |
| MDR Report Key | 9874518 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-24 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2019-01-23 |
| Date Added to Maude | 2020-03-24 |
| 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.-BRAZIL |
| Manufacturer Street | RODOVIA PRESIDENTE DUTRA KM 154 |
| Manufacturer City | SAO PAOLO 12240-908 |
| Manufacturer Country | BR |
| Manufacturer Postal Code | 12240-908 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ETHILON*BLACK4-0 45CM (1)CP-25 |
| Generic Name | SUTURE, NONABSORBABLE, SYNTHETIC |
| Product Code | GAR |
| Date Received | 2020-03-24 |
| Catalog Number | 15502T |
| Lot Number | AL6806 |
| 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 | 2020-03-24 |