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 2017-08-01 for MONOMAX VIOLET 1(4)200CM HRT48 LOOP(M B0041231 manufactured by B.braun Surgical Sa.
[81578566]
(b)(4). Manufacturing site evaluation: evaluation on-going. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[81578567]
Country of complaint: (b)(6). It was reported that the thread had degraded from the package. Some thread was not strong enough to hold and the abdomen would re-open.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003639970-2017-00407 |
| MDR Report Key | 6758609 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-08-01 |
| Date of Report | 2017-10-27 |
| Date Facility Aware | 2017-07-28 |
| Date Mfgr Received | 2017-07-14 |
| Date Added to Maude | 2017-08-01 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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)200CM HRT48 LOOP(M |
| Generic Name | SUTURES |
| Product Code | NWJ |
| Date Received | 2017-08-01 |
| Model Number | B0041231 |
| Catalog Number | B0041231 |
| Lot Number | 114491 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 1. Other | 2017-08-01 |