MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,user faci report with the FDA on 2019-06-26 for 3.5MM STERLING SPHERICAL BUR H9110 manufactured by Conmed Corporation.
| Report Number | 1017294-2019-00068 |
| MDR Report Key | 8734491 |
| Report Source | DISTRIBUTOR,FOREIGN,USER FACI |
| Date Received | 2019-06-26 |
| Date of Report | 2019-06-26 |
| Date of Event | 2019-04-25 |
| Date Mfgr Received | 2019-05-29 |
| Device Manufacturer Date | 2018-11-06 |
| Date Added to Maude | 2019-06-26 |
| 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 | MELANIE LANNON |
| Manufacturer Street | 11311 CONCEPT BOULEVARD |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995209 |
| Manufacturer G1 | CONMED CORPORATION |
| Manufacturer Street | 11311 CONCEPT BOULEVARD |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33773 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3.5MM STERLING SPHERICAL BUR |
| Generic Name | ARTHROSCOPIC SHAVER/BUR |
| Product Code | GFF |
| Date Received | 2019-06-26 |
| Returned To Mfg | 2019-06-14 |
| Model Number | H9110 |
| Catalog Number | H9110 |
| Lot Number | 969458 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | 11311 CONCEPT BOULEVARD LARGO FL 33773 US 33773 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-06-26 |