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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHATTANOOGA PHARMACAL CO.HYDROCOLLATOR

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CHATTANOOGA PHARMACAL CO. HYDROCOLLATOR   Back to Search Results
Model Number M-2
Event Date 11/07/1996
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

During a hot pack treatment, pt developed a burn on right elbow. Pt was admitted for rehabilitation for central cord syndrome. Event occurred during the inpatient stay.

 
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Brand NameHYDROCOLLATOR
Type of DeviceHYDROCOLLATOR
Manufacturer (Section F)
CHATTANOOGA PHARMACAL CO.
4717 adams rd
po box 489
hixson TN 37343 0489
Manufacturer (Section D)
CHATTANOOGA PHARMACAL CO.
4717 adams rd
po box 489
hixson TN 37343 0489
Device Event Key75783
MDR Report Key76033
Event Key71612
Report Number76033
Device Sequence Number1
Product CodeIMA
Report Source User Facility
Reporter Occupation OCCUPATIONAL THERAPIST
Type of Report Initial
Report Date 01/17/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/17/1997
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberM-2
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/17/1997
Device Age20 yr
Event Location Hospital
Date Report TO Manufacturer01/17/1997
Is the Device an Implant? No
Is this an Explanted Device?

Patient TREATMENT DATA
Date Received: 01/17/1997 Patient Sequence Number: 1
#TreatmentTreatment Date
NA
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