MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-23 for SLING UNIV HIGH SPACER LARGE 9153649442 UNKNOWN manufactured by Unknown.
[32114759]
Should additional information become available a supplemental record will be filed.
Patient Sequence No: 1, Text Type: N, H10
[32114760]
Customer states the slings are fraying around the edges.
Patient Sequence No: 1, Text Type: D, B5
[35150040]
The device was returned and the sling was fond to be frayed.
Patient Sequence No: 1, Text Type: N, H10
[35150041]
Customer states the slings are fraying around the edges.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1525712-2015-05497 |
| MDR Report Key | 5242479 |
| Date Received | 2015-11-23 |
| Date of Report | 2015-11-13 |
| Date Mfgr Received | 2015-11-13 |
| Date Added to Maude | 2015-11-23 |
| 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 | 3 |
| Event Location | 3 |
| 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 | SLING UNIV HIGH SPACER LARGE 9153649442 |
| Generic Name | SLING, OVERHEAD SUSPENSION, WHEELCHAIR |
| Product Code | KNO |
| Date Received | 2015-11-23 |
| Returned To Mfg | 2015-11-13 |
| Model Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| 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 | 2015-11-23 |