MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2015-06-10 for FULL BODY W/COMMODE MESH LRG. 9153632098 R115 manufactured by Unknown.
[17208702]
The alleged malfunction was the r115 sling was fraying and ripping at the seams for the straps.
Patient Sequence No: 1, Text Type: D, B5
[17526335]
A returned was issued and the product was evaluated upon receipt. A follow up will be filed if/when any additional information is provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1525712-2015-03368 |
| MDR Report Key | 4835623 |
| Report Source | 08 |
| Date Received | 2015-06-10 |
| Date of Report | 2015-05-13 |
| Date Mfgr Received | 2015-05-13 |
| Date Added to Maude | 2015-07-09 |
| 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 44035 |
| Manufacturer Country | US |
| Manufacturer Postal | 44035 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | UNKNOWN |
| Manufacturer City | OH |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FULL BODY W/COMMODE MESH LRG. 9153632098 |
| Generic Name | SLING, OVERHEAD SUSPENSION, WHEELCHAIR |
| Product Code | INE |
| Date Received | 2015-06-10 |
| Returned To Mfg | 2015-06-04 |
| Model Number | R115 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-06-10 |