MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2015-01-15 for FULL BODY SLING SOLID XLARGE 9153632100 R117 manufactured by Unknown.
[5377281]
The caller states that while lifting the patient, the strap tore away from the sling itself and dropped the patient. The caller states this caused the patient to be dropped. The caller states they did x-ray's but no injuries were found. The caller stated she believes the end user was trying to get more pain meds. The caller believes the unit was bought in 2013. The caller believes the slings were laundered improperly, causing the items to become defective. The caller states that they use an outside laundry service, and they have turned the slings to a pink color from the dark color, due to possible bleaching. No further information available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1525712-2015-00350 |
| MDR Report Key | 4420168 |
| Report Source | 08 |
| Date Received | 2015-01-15 |
| Date of Report | 2015-01-05 |
| Date Mfgr Received | 2015-01-05 |
| Date Added to Maude | 2015-02-05 |
| 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 44036 |
| Manufacturer Country | US |
| Manufacturer Postal | 44036 |
| 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 SLING SOLID XLARGE 9153632100 |
| Generic Name | SLING, OVERHEAD SUSPENSION, WHEELCHAIR |
| Product Code | INE |
| Date Received | 2015-01-15 |
| Model Number | R117 |
| 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 | 1. Other | 2015-01-15 |