MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-20 for FOMON BLACK DIAMOND PUSH/PULL RASP B53098 manufactured by Black & Black Surgical, Inc..
| Report Number | 3006142527-2019-00002 |
| MDR Report Key | 8720694 |
| Date Received | 2019-06-20 |
| Date of Report | 2019-06-20 |
| Date of Event | 2019-05-20 |
| Date Mfgr Received | 2019-05-21 |
| Device Manufacturer Date | 2018-03-01 |
| Date Added to Maude | 2019-06-20 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CYNTHIA REES |
| Manufacturer Street | 5175 S ROYAL ATLANTA DR. |
| Manufacturer City | TUCKER GA 30084 |
| Manufacturer Country | US |
| Manufacturer Postal | 30084 |
| Manufacturer Phone | 7704144880 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FOMON BLACK DIAMOND PUSH/PULL RASP |
| Generic Name | RASP |
| Product Code | HTR |
| Date Received | 2019-06-20 |
| Returned To Mfg | 2019-07-01 |
| Model Number | B53098 |
| Catalog Number | B53098 |
| Lot Number | C18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BLACK & BLACK SURGICAL, INC. |
| Manufacturer Address | 5175 S ROYAL ATLANTA DRIVE TUCKER GA 30084 US 30084 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-06-20 |