MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-05 for GUARDIAN ENVOY 380 GO7981TM manufactured by Medline Industries, Inc..
[182556271]
We ordered the envoy 380 from healthcare supply from wheel walker vehicle but the screw fell out of the lead wheel making the appliance unusable to my (b)(6) y/o dad. We contacted the mfr and they sent another three wheeler. It was defective too as the back wheels were out of alignment. We contacted the company again and have not gotten anywhere with them over this matter. They do not allow phone conversation, only emails. Fda safety report id#. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093555 |
| MDR Report Key | 9799850 |
| Date Received | 2020-03-05 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-02-05 |
| Date Added to Maude | 2020-03-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GUARDIAN ENVOY 380 |
| Generic Name | WALKER, MECHANICAL |
| Product Code | ITJ |
| Date Received | 2020-03-05 |
| Model Number | GO7981TM |
| Lot Number | 88519100003 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-05 |