MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2015-02-04 for ELEVATING LEGREST W/ADJ CALF PAD 9153649407 GT95HC manufactured by Invamex.
[5348926]
Provider states the release lever broke off due to the weld was not holding, reference order (b)(4). Provider stated another coworker placed the order and will connect with him to see what is to be done. No further information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616091-2015-00394 |
| MDR Report Key | 4483272 |
| Report Source | 08 |
| Date Received | 2015-02-04 |
| Date of Report | 2015-01-28 |
| Date Mfgr Received | 2015-01-28 |
| Date Added to Maude | 2015-03-09 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KEVIN GUYTON |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44036 |
| Manufacturer Country | US |
| Manufacturer Postal | 44036 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | INVAMEX |
| Manufacturer Street | PARQUE INDUSTRIAL MANIMEX |
| Manufacturer City | REYNOSA 88780 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88780 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELEVATING LEGREST W/ADJ CALF PAD 9153649407 |
| Generic Name | FOOTREST, WHEELCHAIR |
| Product Code | IMM |
| Date Received | 2015-02-04 |
| Model Number | GT95HC |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVAMEX |
| Manufacturer Address | PARQUE INDUSTRIAL MANIMEX REYNOSA 88780 MX 88780 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-02-04 |