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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION MESH PROLOOP PLUGS MESH, SURGICAL, POLYMERIC

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ATRIUM MEDICAL CORPORATION MESH PROLOOP PLUGS MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 30902
Device Problem Insufficient Information (3190)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
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Brand NameMESH PROLOOP PLUGS
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
40 continental blvd
merrimack NH
Manufacturer (Section G)
ATRIUM MEDICAL CORPORATION
40 continental blvd
merrimack NH
Manufacturer Contact
40 continental blvd
merrimack, NH 
MDR Report Key11592230
Report Number3011175548-2021-00389
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK930669
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Type of Report Initial
Report Date 03/30/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/30/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/31/2015
Device MODEL Number30902
Device Catalogue Number30902
Device LOT Number10702723
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/22/2021
Was Device Evaluated By Manufacturer? No
Date Device Manufactured11/08/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 03/30/2021 Patient Sequence Number: 1
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