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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-D8-12X14
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Scar Tissue (2060)
Event Date 10/05/2020
Event Type  Injury  
Event Description
There was a suspected case of re-prolapse.In the course of the operation, the patient was observed of having a space-occupying scarring.The scar tissue was removed and the barricaid device was removed.The implant was observed to be intact and in good condition prior to re-operation.
 
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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 Key10779494
MDR Text Key214378275
Report Number3006232063-2020-00007
Device Sequence Number1
Product Code QES
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P160050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation Physician
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/30/2019
Device Model NumberBAR-D8-12X14
Device Catalogue NumberBAR-D8-12X14
Device Lot Number03211606-9
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/13/2020
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/05/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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