BED BUDDY BBF5085-12

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-30 for BED BUDDY BBF5085-12 manufactured by .

Event Text Entries

[83988636] A user returned the hot & cold back wrap - the user complained that it had burned her back. The user showed the store floor leader the burns, in which she took pictures of, and left in the store's office, along with the product. No further response was received regarding this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012316249-2017-00107
MDR Report Key6830894
Date Received2017-08-30
Date of Report2017-08-30
Date Facility Aware2017-08-01
Report Date2017-08-30
Date Reported to FDA2017-08-30
Date Added to Maude2017-08-30
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
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 NameBED BUDDY
Generic NameHOT & COLD BACK WRAP
Product CodeIME
Date Received2017-08-30
Model NumberBBF5085-12
Catalog NumberBBF5085-12
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-08-30

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