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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CRYOLIFE, INC. BIOGLUE SYRINGE 5-PACK, 10 ML, JAPAN; GLUE,SURGICAL,ARTERIES

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CRYOLIFE, INC. BIOGLUE SYRINGE 5-PACK, 10 ML, JAPAN; GLUE,SURGICAL,ARTERIES Back to Search Results
Model Number BG3510-5-J
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pseudoaneurysm (2605)
Event Type  Injury  
Event Description
According to the initial report, "the false aneurysm was observed.".
 
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Brand Name
BIOGLUE SYRINGE 5-PACK, 10 ML, JAPAN
Type of Device
GLUE,SURGICAL,ARTERIES
Manufacturer (Section D)
CRYOLIFE, INC.
1655 roberts blvd. nw
kennesaw GA 30144
Manufacturer (Section G)
CRYOLIFE, INC.
1655 roberts blvd. nw
kennesaw GA 30144
Manufacturer Contact
rochelle maney
1655 roberts blvd. nw
kennesaw, GA 30144
7704193355
MDR Report Key13120663
MDR Text Key285679756
Report Number1063481-2021-00040
Device Sequence Number1
Product Code MUQ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P010003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model NumberBG3510-5-J
Device Lot NumberBG000025, BG000052, BG000134
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date12/03/2021
Initial Date Manufacturer Received 12/03/2021
Initial Date FDA Received12/30/2021
Supplement Dates Manufacturer Received12/03/2021
Supplement Dates FDA Received03/03/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
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