MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-10-18 for HARH36 HARH36RR manufactured by Stryker Sustainability Solutions Lakeland.
| Report Number | 0001056128-2019-00055 |
| MDR Report Key | 9210218 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-10-18 |
| Date of Report | 2019-10-18 |
| Date of Event | 2019-08-01 |
| Date Mfgr Received | 2019-09-25 |
| Device Manufacturer Date | 2019-04-04 |
| Date Added to Maude | 2019-10-18 |
| 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 | MR. MARISSA RICHMOND |
| Manufacturer Street | 1810 W. DRAKE DRIVE |
| Manufacturer City | TEMPE AZ 85283 |
| Manufacturer Country | US |
| Manufacturer Postal | 85283 |
| Manufacturer Phone | 8888883433 |
| Manufacturer G1 | STRYKER SUSTAINABILITY SOLUTIONS LAKELAND |
| Manufacturer Street | 5300 REGION CT |
| Manufacturer City | LAKELAND FL 33815 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33815 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NA |
| Generic Name | SCALPEL, ULTRASONIC, REPROCESSED |
| Product Code | NLQ |
| Date Received | 2019-10-18 |
| Returned To Mfg | 2019-08-30 |
| Model Number | HARH36 |
| Catalog Number | HARH36RR |
| Lot Number | 10133185 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER SUSTAINABILITY SOLUTIONS LAKELAND |
| Manufacturer Address | 5300 REGION CT LAKELAND FL 33815 US 33815 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-18 |