READYBATH SHAMPOO CAP *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-07-22 for READYBATH SHAMPOO CAP * manufactured by Medline Industries, Inc..

Event Text Entries

[19144948] One of the nurses noted that the instructions on the readybath shampoo cap indicate the cap can be heated in the microwave for no more than 30 seconds, but does not indicate at what temperature. The instructions caution that heating time may vary according to wattage. The company asked for additional guidance from the local representative, and was given two options: 1) heat in an 800 watt microwave for no more than 30 seconds, or 2) heat in the microwave warmers provided by medline. The company will suggest including the recommended wattage in the instructions to give users some sort of guideline as to duration of heating based on the strength of their microwave if they are not using the manufacturer's warmer.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number541922
MDR Report Key541922
Date Received2004-07-22
Date of Report2004-07-22
Date of Event2004-07-17
Report Date2004-07-22
Date Reported to FDA2004-07-22
Date Added to Maude2004-09-07
Event Key0
Report Source CodeUser Facility 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 Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameREADYBATH SHAMPOO CAP
Generic NameDISPOSABLE SHAMPOO CAP
Product CodeFYF
Date Received2004-07-22
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device AvailabilityN
Device Age*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key531265
ManufacturerMEDLINE INDUSTRIES, INC.
Manufacturer AddressONE MEDLINE PLACE MUNDELEIN IL 60060 US


Patients

Patient NumberTreatmentOutcomeDate
10 2004-07-22

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