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Adverse Event Report

DERMA CONTROL, INC. PHOTOTHERAPY BOOTH   back to search results
Model Number 42UVB
Patient Outcome  Other;
Event Description

Pt receiving phototherapy sustained second degree burns to lower extremity due to timer malfunction. Pt sustained no residual effects and had a full recovery.

 
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Brand NamePHOTOTHERAPY BOOTH
Type of DevicePHOTOTHERAPY BOOTH
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
DERMA CONTROL, INC.
po box 667
frankfort IL 60423
Device Event Key30258
MDR Report Key29236
Event Key27399
Report NumberMW1008052
Device Sequence Number1
Product CodeKGL
Report Source Voluntary
Report Date 09/21/1995
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/04/1996
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number42UVB
Was Device Available For Evaluation? Yes
Is the Device an Implant? No
Is this an Explanted Device?

Database last updated on December 31, 2008

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