MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-15 for SLING UNIV HIGH SPACER LARGE 9153649442 UNKNOWN manufactured by Unknown.
[34142388]
Should additional information become available a supplemental record will be filed.
Patient Sequence No: 1, Text Type: N, H10
[34142389]
The caller initially called in to find out information about the colors of the loops on the sling. I emailed the caller a sling glossy sell sheet with information regarding the color loops on the sling as far as what each color represents. The caller stated that they were using an invacare sling and they had it hooked up to the lift and the black loop broke. The caller is stating that the black loop broke while the lift had the patient in the air over the patients' bed and caused the patient to fall back onto the bed. The caller stated that the patient was injured because it broke while the patient was over the bed. The caller stated that the sling has been washed so many times that they are unable to identify what model sling it is and that it was a full body sling. She stated that they use a power reliant 450 lift. The caller stated that they were calling because they wanted to verify if they were using the sling appropriately. The caller for some reason thought that the person that was operating the lift was not supposed to be using the black loop and she wanted some information or literature on how the sling should hook up to the lift. No additional information provided. Update from 12/11/2015 added by consumer affairs: reporter clarified there was no injury to the patient. Patient was over the bed and almost to the bed when it happened. She said her reason for calling was to find out if they should use the black strap they were using and to get a copy of the user manual and get some information. She confirmed again the patient was not injured. No further information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1525712-2015-05746 |
| MDR Report Key | 5297054 |
| Date Received | 2015-12-15 |
| Date of Report | 2015-12-03 |
| Date Mfgr Received | 2015-12-03 |
| Date Added to Maude | 2015-12-15 |
| 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 | OTHER CAREGIVERS |
| 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 | 0 |
| Brand Name | SLING UNIV HIGH SPACER LARGE 9153649442 |
| Generic Name | SLING, OVERHEAD SUSPENSION, WHEELCHAIR |
| Product Code | INE |
| Date Received | 2015-12-15 |
| Model Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| 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 | 2015-12-15 |