MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-18 for WAX, BONE BW25G manufactured by Cp Medical.
[95258218]
During surgery, it was reported that the product had a bad texture and bad support in the bone with difficult use resulting to an absence of hemostatic effect. There was an appeared of a hematoma and another surgery had been necessary to resolve the case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5074094 |
| MDR Report Key | 7128153 |
| Date Received | 2017-12-18 |
| Date of Report | 2017-12-15 |
| Date of Event | 2017-05-17 |
| Date Added to Maude | 2017-12-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WAX, BONE |
| Generic Name | BONE WAX |
| Product Code | MTJ |
| Date Received | 2017-12-18 |
| Model Number | BW25G |
| Catalog Number | BW25G |
| Lot Number | 160414-58 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CP MEDICAL |
| Manufacturer Address | NORCROSS GA 30093 US 30093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-18 |