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 2018-01-08 for MONOMAX VIOLET 1(4)150CM HR48 LOOP(M) B0041119 manufactured by B.braun Surgical Sa.
[96772345]
(b)(4). Manufacturing site evaluation: evaluation on-going. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[96772346]
Country of complaint: (b)(6). Thread broken very easily.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003639970-2018-00021 |
| MDR Report Key | 7173637 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-01-08 |
| Date of Report | 2018-01-17 |
| Date of Event | 2017-11-13 |
| Date Facility Aware | 2017-12-22 |
| Date Mfgr Received | 2017-12-18 |
| Device Manufacturer Date | 2014-06-05 |
| Date Added to Maude | 2018-01-08 |
| 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 | MS. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| Manufacturer G1 | B.BRAUN SURGICAL SA |
| Manufacturer Street | 121 CARRETERA DE TERRASSA |
| Manufacturer City | RUBI, BARCELONA 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 1(4)150CM HR48 LOOP(M) |
| Generic Name | SUTURES |
| Product Code | NWJ |
| Date Received | 2018-01-08 |
| Model Number | B0041119 |
| Catalog Number | B0041119 |
| Lot Number | 114234V168 |
| Device Expiration Date | 2019-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 3 YR |
| 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 | 1. Other | 2018-01-08 |