MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-01-29 for SMART STAPES PISTON .6 X 4.50 MM 70145928 manufactured by Gyrus Acmi, Inc.
| Report Number | 2951238-2020-00323 |
| MDR Report Key | 9644891 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-01-29 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-01-08 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2019-04-17 |
| Date Added to Maude | 2020-01-29 |
| 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 | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355124 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMART STAPES PISTON .6 X 4.50 MM |
| Generic Name | SMART STAPES PISTON |
| Product Code | ETB |
| Date Received | 2020-01-29 |
| Returned To Mfg | 2019-01-22 |
| Model Number | 70145928 |
| Lot Number | SM853523 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-29 |