ISOLATION GOWN W/THUMB LOOP NONTH100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-07-28 for ISOLATION GOWN W/THUMB LOOP NONTH100 manufactured by *.

Event Text Entries

[67337] A nurse technician was wearing an isolation gown while bathing an infant under a radiant warmer when the sleeves on the gown started to melt. Technician went to the emergency room. Technician received first degree burns on both arms. Unable to determine if it was a medine distributed gown until 7/24/97. Unable to identify the mfr as no lot number was reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1417592-1997-00029
MDR Report Key108499
Date Received1997-07-28
Date of Report1997-07-28
Date of Event1997-06-24
Date Facility Aware1997-07-09
Report Date1997-07-28
Date Reported to FDA1997-07-28
Date Added to Maude1997-07-30
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameISOLATION GOWN W/THUMB LOOP
Generic NameISOLATION GOWN W/THUMB LOOP
Product CodeFYC
Date Received1997-07-28
Model NumberNA
Catalog NumberNONTH100
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age*
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key106638
Manufacturer*
Manufacturer Address* * *


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1997-07-28

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