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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GIVEN IMAGING LTD., YOQNEAM BRAVO; ELECTRODE, PH, STOMACH
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GIVEN IMAGING LTD., YOQNEAM BRAVO; ELECTRODE, PH, STOMACH Back to Search Results
Model Number FGS-0636
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Chest Pain (1776)
Event Date 10/04/2022
Event Type  Injury  
Event Description
According to the reporter, the patient experienced chest pain after the procedure.The patient had limited intake during their the procedure and treated with gi cocktail, tylenol, advil, levsin for chest spasms.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
BRAVO
Type of Device
ELECTRODE, PH, STOMACH
Manufacturer (Section D)
GIVEN IMAGING LTD., YOQNEAM
yetsira 13 street
yoqneam 20692
IS  20692
Manufacturer (Section G)
GIVEN IMAGING LTD., YOQNEAM
yetsira 13 street
yoqneam 20692
IS   20692
Manufacturer Contact
justin ellis
8200 coral sea st ne
mounds view, MN 55112
7635265677
MDR Report Key15773658
MDR Text Key303537903
Report Number9710107-2022-00239
Device Sequence Number1
Product Code FFT
UDI-Device Identifier07290101369714
UDI-Public07290101369714
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102543
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 11/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFGS-0636
Device Catalogue NumberFGS-0636
Device Lot Number57065F
Was Device Available for Evaluation? No
Date Manufacturer Received10/26/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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