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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - SAINT PAUL GEM FLOW COUPLER DEVICE AND SYSTEM ANASTOMOTIC COUPLER AND FLOW METER

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BAXTER HEALTHCARE - SAINT PAUL GEM FLOW COUPLER DEVICE AND SYSTEM ANASTOMOTIC COUPLER AND FLOW METER Back to Search Results
Model Number GEM2752-FC
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Tissue Damage (2104)
Event Date 02/09/2018
Event Type  Injury  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a surgeon implanted a 2. 0mm gem flow coupler during a free flap breast reconstruction operation and believed to have heard flow coupler doppler sound. The surgeon now believes there was no blood flow in the flap vein. The patient lost the flap. Additional information is not available.
 
Manufacturer Narrative
The actual device was not available for evaluation. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. The device was not received for evaluation; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted. Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand NameGEM FLOW COUPLER DEVICE AND SYSTEM
Type of DeviceANASTOMOTIC COUPLER AND FLOW METER
Manufacturer (Section D)
BAXTER HEALTHCARE - SAINT PAUL
saint paul MN
Manufacturer (Section G)
BAXTER HEALTHCARE - SAINT PAUL
2575 university ave w
saint paul MN 55114
Manufacturer Contact
2242702068
MDR Report Key7430479
MDR Text Key105454612
Report Number1416980-2018-02128
Device Sequence Number1
Product Code MVR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132727
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/08/2019
Device Model NumberGEM2752-FC
Device Catalogue Number515101200010
Device Lot NumberSP17F08-1234606
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/08/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/13/2018 Patient Sequence Number: 1
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