HYDROCOLLATOR M-2 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-01-17 for HYDROCOLLATOR M-2 NA manufactured by Chattanooga Pharmacal Co..

Event Text Entries

[45820] Pt sustained burn to left scapula after hot pack treatment.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number76035
MDR Report Key76035
Date Received1997-01-17
Date of Report1997-01-17
Date of Event1996-11-06
Date Facility Aware1996-11-06
Report Date1997-01-17
Date Reported to FDA1997-01-17
Date Reported to Mfgr1997-01-17
Date Added to Maude1997-03-17
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPHYSICAL THERAPIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameHYDROCOLLATOR
Generic NameHYDROCOLLATOR
Product CodeIMA
Date Received1997-01-17
Model NumberM-2
Catalog NumberNA
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age20 YR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key75785
ManufacturerCHATTANOOGA PHARMACAL CO.
Manufacturer Address4717 ADAMS RD PO BOX 489 HIXSON TN 373430489 US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1997-01-17

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