MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-07 for JAZZ STANDARD ROLLATOR 9153653681 NA:JAZZSTD JAZZSTD manufactured by Dolomite.
| Report Number | 9615290-2020-00002 |
| MDR Report Key | 9681464 |
| Report Source | CONSUMER |
| Date Received | 2020-02-07 |
| Date of Report | 2020-01-09 |
| Date Mfgr Received | 2020-01-09 |
| Device Manufacturer Date | 2012-10-01 |
| Date Added to Maude | 2020-02-07 |
| 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 | MR. JASON FIEST |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44035 |
| Manufacturer Country | US |
| Manufacturer Postal | 44035 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | DOLOMITE |
| Manufacturer Street | V |
| Manufacturer City | DI 343 71 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 343 71 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JAZZ STANDARD ROLLATOR 9153653681 |
| Generic Name | WALKER, MECHANICAL |
| Product Code | ITJ |
| Date Received | 2020-02-07 |
| Model Number | NA:JAZZSTD |
| Catalog Number | JAZZSTD |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DOLOMITE |
| Manufacturer Address | BOX 200 VAXJOVAGEN 303 DI?, SWEDEN 343 71 SW 343 71 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-02-07 |