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 2019-06-27 for TC MAYO-HEGAR NDL HOLDERHVYSERR205MM BM067R manufactured by B/ Braun Surgical Sa.
| Report Number | 9610612-2019-00431 |
| MDR Report Key | 8741305 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-06-27 |
| Date of Report | 2019-07-29 |
| Date of Event | 2019-05-24 |
| Date Facility Aware | 2019-06-24 |
| Date Mfgr Received | 2019-07-03 |
| Device Manufacturer Date | 2018-11-15 |
| Date Added to Maude | 2019-06-27 |
| 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 | 121 CARRETERA DE TERRASSA |
| Manufacturer City | RUBI, PA 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 | TC MAYO-HEGAR NDL HOLDERHVYSERR205MM |
| Generic Name | BASIC INSTRUMENTS |
| Product Code | HXK |
| Date Received | 2019-06-27 |
| Model Number | BM067R |
| Catalog Number | BM067R |
| Lot Number | 4510082752 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 190 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 | 2019-06-27 |