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 2020-03-19 for MONOPLUS VIOLET 1 (4) 90CM HR48 (M) C0024078 manufactured by B. Braun Surgical, S.a..
[184417430]
If additional information becomes available a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[184417431]
It was reported that there was an issue with monoplus suture. The client reported that when opening the package, detachment of thread and needle was found. Thus, this product could not be used for the surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003639970-2020-00164 |
| MDR Report Key | 9855722 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-24 |
| Date Added to Maude | 2020-03-19 |
| 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. SILVIA ORUS |
| Manufacturer Street | CARRETERA DE TERRASSA, 121 |
| Manufacturer City | RUBI, BARCELONA 08191 |
| Manufacturer Country | SP |
| Manufacturer Postal | 08191 |
| Manufacturer G1 | B/ BRAUN SURGICAL SA |
| Manufacturer Street | 121 CARRETERA DE TERRASSA |
| Manufacturer City | RUBI, 08191 |
| Manufacturer Country | SP |
| Manufacturer Postal Code | 08191 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MONOPLUS VIOLET 1 (4) 90CM HR48 (M) |
| Generic Name | SYNTHETIC ABSORBABLE MONOFILAR |
| Product Code | NEW |
| Date Received | 2020-03-19 |
| Returned To Mfg | 2020-03-19 |
| Model Number | C0024078 |
| Catalog Number | C0024078 |
| Lot Number | 119454 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN SURGICAL, S.A. |
| Manufacturer Address | CARRETERA DE TERRASSA 121 RUB?, BARCELONA 08191 SP 08191 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-19 |