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 2019-06-04 for MONOMAX VIOLET 1(4)150CM HRT48 LOOP(M B0041222 manufactured by B.braun Surgical Sa.
| Report Number | 3003639970-2019-00454 |
| MDR Report Key | 8668583 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-06-04 |
| Date of Report | 2019-06-04 |
| Date Facility Aware | 2019-05-22 |
| Date Mfgr Received | 2019-05-08 |
| Date Added to Maude | 2019-06-04 |
| 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. LINDSAY CHROMIAK |
| Manufacturer Street | 3773 CORPORATE PARKWAY |
| Manufacturer City | CENTER VALLEY PA 18034 |
| Manufacturer Country | US |
| Manufacturer Postal | 18034 |
| Manufacturer Phone | 8002581946 |
| 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 1(4)150CM HRT48 LOOP(M |
| Generic Name | SYNTHETIC ABSORBABLE MONOFILAR |
| Product Code | NWJ |
| Date Received | 2019-06-04 |
| Returned To Mfg | 2019-05-15 |
| Model Number | B0041222 |
| Catalog Number | B0041222 |
| Lot Number | 118516 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2019-06-04 |