MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-27 for MAXIMA DISPOSABLE SAFETY SCALPEL 570-0246 manufactured by Sinapi Biomedical (pty) Ltd.
| Report Number | 1058382-2019-00005 |
| MDR Report Key | 9132147 |
| Date Received | 2019-09-27 |
| Date of Report | 2019-09-27 |
| Date of Event | 2019-09-18 |
| Date Facility Aware | 2019-09-20 |
| Report Date | 2019-09-27 |
| Date Reported to FDA | 2019-09-27 |
| Date Reported to Mfgr | 2019-09-20 |
| Date Added to Maude | 2019-09-27 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | MAXIMA DISPOSABLE SAFETY SCALPEL |
| Generic Name | SAFETY SCALPEL |
| Product Code | GES |
| Date Received | 2019-09-27 |
| Catalog Number | 570-0246 |
| Lot Number | 1703710 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 30 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SINAPI BIOMEDICAL (PTY) LTD |
| Manufacturer Address | ARC-INFRUITEC NORTH CAMPUS LELIE ROAD STELLENBOSCH, 7600 SF 7600 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-27 |