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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC. SECHRIST CHAMBERS HYPERBARIC OXYGEN CHAMBER

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SECHRIST INDUSTRIES, INC. SECHRIST CHAMBERS HYPERBARIC OXYGEN CHAMBER Back to Search Results
Model Number 3200
Event Date 01/28/2011
Event Type  Injury  
Event Description

Pt received treatment in a hyperbaric oxygen chamber. He has received 60 similar treatments. When coming out from the chamber, the pt complained of visual loss in both eyes. Pt has received follow up care from an eye specialist. He has been recovering his visual ability.

 
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Brand NameSECHRIST CHAMBERS
Type of DeviceHYPERBARIC OXYGEN CHAMBER
Manufacturer (Section D)
SECHRIST INDUSTRIES, INC.
4225 e la palma ave
anaheim CA 92807
MDR Report Key1987884
Report NumberMW5019364
Device Sequence Number1
Product CodeCBF
Report Source Voluntary
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 02/08/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/08/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number3200
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 02/08/2011 Patient Sequence Number: 1
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