TOLLOS DISPOSABLE FULL LENGTH REPOSITIONING SLING - BARIATRIC TA80LB-PSS

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report Number6459734
MDR Report Key6459734
Date Received2017-04-05
Date of Report2017-03-30
Date of Event2017-03-07
Report Date2017-03-30
Date Reported to FDA2017-03-30
Date Reported to Mfgr2017-03-30
Date Added to Maude2017-04-05
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTOLLOS DISPOSABLE FULL LENGTH REPOSITIONING SLING - BARIATRIC
Generic NameTOLLOS DISPOSABLE LINEN
Product CodeKME
Date Received2017-04-05
Catalog NumberTA80LB-PSS
ID NumberMFR. DATE: 2016 SEP
OperatorNURSE
Device Availability*
Device Age1 DY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerXIANTAO YONGLI MEDICAL PRODUCTS CORP. LTD
Manufacturer AddressONE EASTER COURT SUITE J GARRISON MD 21117 US 21117


Patients

Patient NumberTreatmentOutcomeDate
10 2017-04-05

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