MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-20 for STIMULAN manufactured by Biocomposites Ltd..
| Report Number | MW5089948 |
| MDR Report Key | 9104145 |
| Date Received | 2019-09-20 |
| Date of Report | 2019-09-18 |
| Date of Event | 2019-09-16 |
| Date Added to Maude | 2019-09-23 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Brand Name | STIMULAN |
| Generic Name | FILLER, BONE VOID, CALCIUM COMPOUND |
| Product Code | MQV |
| Date Received | 2019-09-20 |
| Lot Number | 01/19-R391/393 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOCOMPOSITES LTD. |
| Brand Name | STIMULAN |
| Generic Name | FILLER, BONE VOID, CALCIUM COMPOUND |
| Product Code | MQV |
| Date Received | 2019-09-20 |
| Lot Number | SR190508 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | BIOCOMPOSITES LTD. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-09-20 |