MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-08-22 for HR004, S/M ALEXIS ORTHO PROT 5/BX 101428801 manufactured by Applied Medical Resources.
| Report Number | 2027111-2019-00567 |
| MDR Report Key | 8923687 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-08-22 |
| Date of Report | 2019-08-22 |
| Date of Event | 2019-08-12 |
| Date Mfgr Received | 2019-08-12 |
| Device Manufacturer Date | 2018-11-16 |
| Date Added to Maude | 2019-08-22 |
| 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 | WENDY KOBAYASHI |
| Manufacturer Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal | 92688 |
| Manufacturer Phone | 9497138059 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HR004, S/M ALEXIS ORTHO PROT 5/BX |
| Generic Name | RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL |
| Product Code | KGW |
| Date Received | 2019-08-22 |
| Model Number | HR004 |
| Catalog Number | 101428801 |
| Lot Number | 1342113 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL RESOURCES |
| Manufacturer Address | 22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US 92688 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-22 |