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 2020-03-16 for SILKAM BLACK 1 (4) 75CM DS30 C0762490 manufactured by B. Braun Surgical, S.a..
[183567746]
If additional information becomes available a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[183567747]
It was reported that there was an issue with silkam suture. The client reported that the thread breaks when tightening the knot during pacemaker implantation surgery. The thread is too fragile. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003639970-2020-00153 |
| MDR Report Key | 9836193 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-01-08 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2019-08-14 |
| Date Added to Maude | 2020-03-16 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS S OR |
| Manufacturer Street | CARRETERA DE TERRASSA, 121 |
| Manufacturer City | RUB 08191 |
| Manufacturer Country | SP |
| Manufacturer Postal | 08191 |
| Manufacturer G1 | B. BRAUN SURGICAL, S.A. |
| Manufacturer Street | CARRETERA DE TERRASSA, 121 |
| Manufacturer City | RUB 08191 |
| Manufacturer Country | SP |
| Manufacturer Postal Code | 08191 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SILKAM BLACK 1 (4) 75CM DS30 |
| Generic Name | OTHER SUTURE |
| Product Code | GAP |
| Date Received | 2020-03-16 |
| Model Number | C0762490 |
| Catalog Number | C0762490 |
| Lot Number | 619333 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN SURGICAL, S.A. |
| Manufacturer Address | CARRETERA DE TERRASSA, 121 RUB?, 08191 SP 08191 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-16 |