MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-10-12 for BONE WAX 24X2.5G 1029754 manufactured by B. Braun Surgical Sa.
[123809815]
(b)(4). Manufacturing site evaluation: date of event: unknown. Pending further information.
Patient Sequence No: 1, Text Type: N, H10
[123809816]
It was reported by the healthcare professional to the company sales representative "after opening the package it was discovered it was empty. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003639970-2018-00661 |
| MDR Report Key | 7960449 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-10-12 |
| Date of Report | 2018-12-12 |
| Date Facility Aware | 2018-11-22 |
| Date Mfgr Received | 2018-11-22 |
| Date Added to Maude | 2018-10-12 |
| 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. 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, 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 | BONE WAX |
| Product Code | MTJ |
| Date Received | 2018-10-12 |
| Model Number | 1029754 |
| Catalog Number | 1029754 |
| Lot Number | 217384 |
| 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 | 2018-10-12 |