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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTRINSIC THERAPEUTICS, INC. BARRICAID ACD
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INTRINSIC THERAPEUTICS, INC. BARRICAID ACD Back to Search Results
Model Number BAR-D8-10MM
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Hernia (2240)
Event Date 01/01/2021
Event Type  Injury  
Manufacturer Narrative
Known inherent risk of device.
 
Event Description
Reherniation with a backflipped mesh.During revision surgery it showed that the mesh was completely detached from the anchor.It was found free in the interspinal canal and easy to remove.The anchor is still in place.
 
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Brand Name
BARRICAID ACD
Type of Device
BARRICAID
Manufacturer (Section D)
INTRINSIC THERAPEUTICS, INC.
30 commerce way
woburn MA 01801
Manufacturer (Section G)
INTRINSIC THERAPEUTICS, INC.
30 commerce way
woburn MA 01801
Manufacturer Contact
regina shih
30 commerce way
woburn, MA 01801
5083696545
MDR Report Key11247347
MDR Text Key229323806
Report Number3006232063-2021-00003
Device Sequence Number1
Product Code QES
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P160050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 01/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date06/19/2023
Device Model NumberBAR-D8-10MM
Device Catalogue NumberBAR-D8-10MM
Device Lot Number11202021
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/15/2020
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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