MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-04 for SLING UNIV HIGH SPACER LARGE 9153649442 UNKNOWN manufactured by Unknown.
[35279039]
Should additional information become available a supplemental record will be filed. User? S manual review (1023891 rev. I, page 6) after each laundering (in accordance with instructions on the sling), 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. The product manufacturer is unknown. Unknown if sling is invacare or pro active. Invacare is one of the possible manufacturers so invacare has chosen to file the 3500a with the fda under the invacare cfn/fei.
Patient Sequence No: 1, Text Type: N, H10
[35279040]
Caller is stating that the sling broke and he is investigating the facility. Caller has been told by the facility that the strap broke on the sling, it detached where it attaches. He also said they cannot find the sling at the facility. He knows the facility uses both invacare and pro active slings, not sure what sling was being used. He knows the sling was ordered in (b)(6) 2014 and failed (b)(6) 2015.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1525712-2015-05997 |
| MDR Report Key | 5339990 |
| Date Received | 2016-01-04 |
| Date of Report | 2015-12-15 |
| Date Mfgr Received | 2015-12-15 |
| Date Added to Maude | 2016-01-04 |
| 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 | RISK MANAGER |
| 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 | 2016-01-04 |
| 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 | 2016-01-04 |