MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-05 for TOLLOS DISPOSABLE FULL LENGTH REPOSITIONING SLING - BARIATRIC TA80LB-PSS manufactured by Xiantao Yongli Medical Products Corp. Ltd.
[71695234]
Patient Sequence No: 1, Text Type: N, H10
[71695255]
Staff was using the ceiling lift (1000lb max) to get the patient from the chair back to bed. They were using the tollos repositioning bariatric sling, that has a max weight of 1000lbs. The patient is around (b)(6). When lifting the patient up, the patient was approximately 1-2 inches above the chair when the lift sheet ripped. This caused the patient to fall back into the chair. No physical harm came to the patient, but he was emotionally upset about what had happened. Rip occurred along a stitched seam. Manufacturer response for bariatric lift sling/sheet, (brand not provided) (per site reporter): unknown at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6459734 |
| MDR Report Key | 6459734 |
| Date Received | 2017-04-05 |
| Date of Report | 2017-03-30 |
| Date of Event | 2017-03-07 |
| Report Date | 2017-03-30 |
| Date Reported to FDA | 2017-03-30 |
| Date Reported to Mfgr | 2017-03-30 |
| Date Added to Maude | 2017-04-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOLLOS DISPOSABLE FULL LENGTH REPOSITIONING SLING - BARIATRIC |
| Generic Name | TOLLOS DISPOSABLE LINEN |
| Product Code | KME |
| Date Received | 2017-04-05 |
| Catalog Number | TA80LB-PSS |
| ID Number | MFR. DATE: 2016 SEP |
| Operator | NURSE |
| Device Availability | * |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | XIANTAO YONGLI MEDICAL PRODUCTS CORP. LTD |
| Manufacturer Address | ONE EASTER COURT SUITE J GARRISON MD 21117 US 21117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-05 |