MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2015-05-12 for AHL4A HEMI SMART LEG ART.LEGS-ALUM 9153619911 AHL4A_PTO_19911 manufactured by Invamex.
[17328228]
Per provider, leg rests were opened out of the box a couple weeks ago. Within a couple days, at the customer's residence, the metal piece that extends the lever broke off on the left side.
Patient Sequence No: 1, Text Type: D, B5
[17526703]
No end user information provided. Serial number not available for front riggings. The product is expected to be returned. A follow-up will be sent if additional information is received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616091-2015-01325 |
| MDR Report Key | 4764474 |
| Report Source | 08 |
| Date Received | 2015-05-12 |
| Date of Report | 2015-04-21 |
| Date Mfgr Received | 2015-04-21 |
| Date Added to Maude | 2015-06-08 |
| 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 44035 |
| Manufacturer Country | US |
| Manufacturer Postal | 44035 |
| 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 | AHL4A HEMI SMART LEG ART.LEGS-ALUM 9153619911 |
| Generic Name | FOOTREST, WHEELCHAIR |
| Product Code | KNN |
| Date Received | 2015-05-12 |
| Model Number | AHL4A_PTO_19911 |
| 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 | 2015-05-12 |