MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-07-14 for SLING UNIV HIGH SPACER LARGE 9153649442 UNKNOWN manufactured by Unknown.
[49494312]
No photographs are available for investigation. Return of sling for investigation is not anticipated; sling was destroyed by the facility. The user? S manual warns that after each laundering, inspect sling(s) for wear, tears, and loose stitching. Bleached, torn, cut, frayed, or broken slings are unsafe and could result in injury. Discard immediately. There is insufficient evidence to completely verify that the product is an invacare device; model and serial number are not available, as it was reported that the sling was destroyed. Based on the report that the facility has various reliant slings and the seriousness of the allegation of death, an mdr will be filed as unknown manufacturer by invacare to (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[49494313]
Per legal department, the lawyer representing the end user alleges in (b)(6) 2014 the end user was being transferred from the wheelchair to the bed on a reliant lift, no model or serial number was provided. Lawyer alleges the sling tore and caused the end user to fall and hit her head on the edge of the bed board with enough force to break the end users neck. Lawyer alleges the end user expired six week later lawyer alleges the end user was being transferred by nursing home staff. Update from consumer affairs on 06/24/2016: the sling was apparently destroyed, so the exact model number/date code will never be confirmed. However, the allegation is that it is a reliant series sling. The facility purchased various reliant slings from 2003-2014 and even the older ones were still in use. The lawsuit alleges that the sling broke loose and she fell out the side and the fall ultimately led to her death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1525712-2016-02457 |
| MDR Report Key | 5793494 |
| Report Source | OTHER |
| Date Received | 2016-07-14 |
| Date of Report | 2016-06-17 |
| Date of Event | 2014-08-15 |
| Date Mfgr Received | 2016-06-17 |
| Date Added to Maude | 2016-07-14 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| 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 | INE |
| Date Received | 2016-07-14 |
| Model Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2016-07-14 |