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 2019-01-24 for BONE WAX 24X2.5G 1029754 manufactured by B.braun Surgical Sa.
[134087784]
(b)(4). Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[134087805]
It was reported that there was an issue with the bone wax. During surgery, the surgeon complained that the bone wax was not sticky. It affected application and he could not smear it directly onto the bone to stop bleeding; instead, he needed to press on the bone with a finger. Patient outcome was not provided but no harm or intervention was noted. No patient information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003639970-2019-00064 |
| MDR Report Key | 8275397 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-24 |
| Date of Report | 2019-02-28 |
| Date of Event | 2018-12-03 |
| Date Facility Aware | 2019-02-26 |
| Date Mfgr Received | 2019-02-26 |
| Date Added to Maude | 2019-01-24 |
| 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 | MRS. NICOLE BROYLES |
| Manufacturer Street | 1 A RAUMANTIE |
| Manufacturer City | HELSINKI MO 00350 |
| Manufacturer Country | FI |
| Manufacturer Postal | 00350 |
| 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 | BONE WAX 24X2.5G |
| Generic Name | HAEMOSTYPTICS |
| Product Code | MTJ |
| Date Received | 2019-01-24 |
| Model Number | 1029754 |
| Catalog Number | 1029754 |
| Lot Number | 218073 |
| 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 | 2019-01-24 |