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 2020-02-05 for MONOMAX VIOLET 0 (3,5) 150CM HR37S(M)DDP B0041043 manufactured by B.braun Surgical Sa.
[178029243]
Investigation on-going. Additional information / investigation results will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[178029244]
It was reported that there was an issue with monomax violet. The customer stated that the sterile inner packaging is stuck at the frontside of the outer pouch. The suture did not reach the sterile field, and therefore has not been used on a patient. There is no further information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003639970-2020-00043 |
| MDR Report Key | 9672492 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-18 |
| Date Mfgr Received | 2020-02-18 |
| Date Added to Maude | 2020-02-05 |
| 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 | SILVIA ORUS |
| Manufacturer Street | 121 CARRETERA DE TERRASSA |
| Manufacturer City | RUBI, 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 | MONOMAX VIOLET 0 (3,5) 150CM HR37S(M)DDP |
| Generic Name | SYNTHETIC ABSORBABLE MONOFILAR |
| Product Code | NWJ |
| Date Received | 2020-02-05 |
| Model Number | B0041043 |
| Catalog Number | B0041043 |
| Lot Number | 119281 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B.BRAUN SURGICAL SA |
| Manufacturer Address | 121 CARRETERA DE TERRASSA RUBI, 08191 SP 08191 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-05 |