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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HIPERBARICAS DEL ECUADOR HYPERBARIC OXYGENATION CHAMBER HYPERBARIC

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HIPERBARICAS DEL ECUADOR HYPERBARIC OXYGENATION CHAMBER HYPERBARIC Back to Search Results
Event Date 07/27/2018
Event Type  Injury  
Event Description

I went to the (b)(6) in (b)(6) after one week of hysterectomy. When i left there i felt bad my "presion" was down and when i arrived to my house i had fever. I called to the center and the receptionist told me that the dr called me. He did not call me and i suspected the other session. My gastroenterologist sent me a test and the results after 2 days is that i have (b)(6) and i have to follow a treatment.

 
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Brand NameHYPERBARIC OXYGENATION
Type of DeviceCHAMBER HYPERBARIC
Manufacturer (Section D)
HIPERBARICAS DEL ECUADOR
km 2.5 via samborondon
edif diana quintana local 3, ec092301
guayaquil 09230 1
EC  092301
MDR Report Key7738937
Report NumberMW5078725
Device Sequence Number1
Product CodeCBF
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 07/29/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/31/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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