COMFORT RINSE-FREE SHAMPOO CAP 7909 UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-09-12 for COMFORT RINSE-FREE SHAMPOO CAP 7909 UNK manufactured by Sage Products Inc..

Event Text Entries

[2162848] Unresponsive, ventilated patient sustained a second degree burn to forehead and nape of neck following use of no-rinse shower cap. Rn heated product according to manufacturer's and product package instructions. Burn noted after cap was removed after approximately five minutes. Physician made aware and ordered silvadene to affected areas and consulted wound care.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2263438
MDR Report Key2263438
Date Received2011-09-12
Date of Report2011-09-12
Date of Event2011-09-11
Report Date2011-09-12
Date Reported to FDA2011-09-12
Date Added to Maude2011-09-26
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameCOMFORT RINSE-FREE SHAMPOO CAP
Generic NameCAP, SURGICAL
Product CodeFYF
Date Received2011-09-12
Model Number7909
Catalog NumberUNK
Lot NumberUNK
ID Number*
OperatorNURSE
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerSAGE PRODUCTS INC.
Manufacturer Address3909 THREE OAKS RD CARY IL 60013 US 60013


Patients

Patient NumberTreatmentOutcomeDate
10 2011-09-12

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