CAPRI BLADDER CONTROL PADS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-13 for CAPRI BLADDER CONTROL PADS manufactured by Medline Industries Inc..

Event Text Entries

[62825474] Here's what i sent to (b)(6) on (b)(6) message about the situation: i have another issue with another bladder control pad. I found this one on here when i took this out of the wrapper. It's not even fair to me to have these kinds of issues with these products again. It looks like someone used it (a tissue or something it's gross and disturbing). They replied back about my number and about someone contacting me which no one has. The first message about it went out on sunday (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5066738
MDR Report Key6185090
Date Received2016-12-13
Date of Report2016-12-13
Date of Event2016-12-10
Date Added to Maude2016-12-19
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameCAPRI BLADDER CONTROL PADS
Generic NameCAPRI BLADDER CONTROL PADS
Product CodeKME
Date Received2016-12-13
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDLINE INDUSTRIES INC.


Patients

Patient NumberTreatmentOutcomeDate
10 2016-12-13

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