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 2018-09-13 for BONE WAX 24X2.5G 1029754 manufactured by B Braun Surgical Sa.
[120156792]
(b)(4). The actual complaint sample was returned for evaluation, a supplemental report will be forwarded at the completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[120156793]
It was reported that the reported by an anonymous end user, that the bone wax is not sticky and made it not possible to stop the bleeding.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003639970-2018-00571 |
| MDR Report Key | 7873496 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-09-13 |
| Date of Report | 2018-11-05 |
| Date of Event | 2018-07-23 |
| Date Facility Aware | 2018-09-03 |
| Date Mfgr Received | 2018-08-23 |
| Date Added to Maude | 2018-09-13 |
| 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 | MRS NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| Manufacturer G1 | AESCULAP USA |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63042 |
| 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 | 2018-09-13 |
| Returned To Mfg | 2018-08-22 |
| Model Number | 1029754 |
| Catalog Number | 1029754 |
| Lot Number | 218082 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2018-09-13 |