MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2020-02-26 for ARROW 265129 - CoCr OFF-CENTRED HUMERAL HEAD, ?48 H16 265129 manufactured by Fh Industrie.
| Report Number | 3003898228-2020-00002 |
| MDR Report Key | 9755018 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-29 |
| Date of Event | 2019-10-23 |
| Date Mfgr Received | 2020-01-29 |
| Device Manufacturer Date | 2013-04-01 |
| Date Added to Maude | 2020-02-26 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. C HERNOUX |
| Manufacturer Street | 3 RUE DE LA FOR |
| Manufacturer City | HEIMSBRUNN, 68990 |
| Manufacturer Country | FR |
| Manufacturer Postal | 68990 |
| Manufacturer G1 | FH INDUSTRIE |
| Manufacturer Street | 6 RUE NOBEL |
| Manufacturer City | QUIMPER, 29000 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 29000 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARROW |
| Generic Name | ARROW GLENOID INSERT 46 |
| Product Code | KWT |
| Date Received | 2020-02-26 |
| Returned To Mfg | 2020-01-29 |
| Model Number | 265129 - CoCr OFF-CENTRED HUMERAL HEAD, ?48 H16 |
| Catalog Number | 265129 |
| Lot Number | G00079 |
| Device Expiration Date | 2019-10-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FH INDUSTRIE |
| Manufacturer Address | 6 RUE NOBEL QUIMPER, 29000 FR 29000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-26 |