BOUNDARY BOUFFANT CAPS REORDER# CRI1004

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-11-19 for BOUNDARY BOUFFANT CAPS REORDER# CRI1004 manufactured by Boundary Medical.

Event Text Entries

[17065004] Pt being prepped for routine dental procedure, after a blue bouffant surgical cap was placed over pt's hair, a red splotchy, small bumps rash was noticed approx ten minutes after placement on pt's head; the rash followed the lines of the elastic band of the cap across the pt's forehead and temple areas of each side of the head; cheeks became pinkish red and pt developed same bumpy rash on the left side of neck and upper mid-chest area; rash was non-itchy and pt did not experience any tongue swelling or difficulty breathing; bouffant cap was removed immediately; and rash began to disappear immediately after removal of the cap. Dates of use: (b)(6) 2010. Diagnosis or reason for use: surgical attire during surgical procedure. Event abated after use stopped or dose reduced? Yes.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5018282
MDR Report Key1908870
Date Received2010-11-19
Date of Report2010-11-19
Date of Event2010-11-11
Date Added to Maude2010-12-06
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameBOUNDARY BOUFFANT CAPS
Generic NameSPUNBOND POLYPROPYLENE
Product CodeFYF
Date Received2010-11-19
Model NumberNA
Catalog NumberREORDER# CRI1004
Lot Number1004845919
ID NumberBAR CODE# (01)30080196745771
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerBOUNDARY MEDICAL
Manufacturer Address4141 WESTMARK DR DUBUQUE IA 52002 US 52002


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2010-11-19

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