CAREX FGB15300 0000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-27 for CAREX FGB15300 0000 manufactured by .

Event Text Entries

[137318755] The transfer bench was purchased about 6 months ago. The user fell 2-3 months ago when the right back leg's pin bent. It threw him backwards in the tub. He hit his shoulder and his back. He wasn't going to say anything, but he still isn't able to raise his right arm up above his head. He doesn't remember who all he has seen about this injury, but he said that he went to a chiropractor who did an x-ray on his arm. The chiropractor didn't know what was wrong. As of (b)(6) 2019 (when serious injury was identified), he's also gone to a clinic, and they told him that his rotator cup is messed up on the left side. They said that there is a strong possibility that the fall caused the problem with his rotator cuff. As of (b)(6) 2019, he is now saying that it is the left arm that he can't lift up above his head - the user was asked to clarify, as he originally reported that it was his right, but he said he injured the left rotator cuff when he fell. He needs to have his knee fixed before he can have his shoulder fixed. His knee wasn't injured as a result of this fall (knee surgery is required, as he has bone on bone). The user insisted that one of the legs on the transfer bench was bent. The device involved with this event was returned to compass health brands on 11/8/2018. The returned unit was found to have a heavy residue of a mildew-like substance. The metal screws on the returned unit were found to be heavily rusted. One c-clip was found to be missing; the backrest was found to have been unscrewed & detached by the user. The returned unit was not bent & no stress points were discovered. Overall, the customer's complaint was unable to be duplicated from a review of the returned device.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012316249-2019-00007
MDR Report Key8375789
Date Received2019-02-27
Date of Report2019-02-27
Date Facility Aware2018-09-21
Report Date2019-02-27
Date Reported to FDA2019-02-27
Date Added to Maude2019-02-27
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
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 NameCAREX
Generic NameTRANSFER BENCH
Product CodeILS
Date Received2019-02-27
Model NumberFGB15300 0000
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Deathisabilit 2019-02-27

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