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 2019-06-21 for HAR36MRH manufactured by Medline Renewal.
| Report Number | 3032391-2019-00013 |
| MDR Report Key | 8722053 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-06-21 |
| Date of Report | 2019-06-21 |
| Date of Event | 2019-06-03 |
| Date Mfgr Received | 2019-06-04 |
| Date Added to Maude | 2019-06-21 |
| 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 | STEPHEN WILSON |
| Manufacturer Street | 1500 NE HEMLOCK AVE |
| Manufacturer City | REDMOND OR 97756 |
| Manufacturer Country | US |
| Manufacturer Postal | 97756 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | HAR36M @HARMONIC ACE+ SHEARS W/OUT ADAPT |
| Product Code | NLQ |
| Date Received | 2019-06-21 |
| Returned To Mfg | 2019-06-11 |
| Catalog Number | HAR36MRH |
| Lot Number | 413882 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE RENEWAL |
| Manufacturer Address | 1500 NE HEMLOCK AVE REDMOND OR 97756 US 97756 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-06-21 |