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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORPORATION PROLITE MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative

Upon completion of the investigation into this event a follow up report will be submitted.

 
Event Description

We have received a report that a physician implanted a prolite mesh, with an expired expiration date. With no injury to patient.

 
Search Alerts/Recalls

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Brand NamePROLITE MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
40 continental blvd
merrimack NH 03054
Manufacturer (Section G)
ATRIUM MEDICAL CORPORATION
40 continental blvd
merrimack NH 03054
Manufacturer Contact
40 continental blvd
merrimack, NH 03054
MDR Report Key10178328
MDR Text Key195896247
Report Number3011175548-2020-00840
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK002093
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 06/22/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/22/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/14/2020
Was Device Evaluated By Manufacturer? No Answer Provided
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: 06/22/2020 Patient Sequence Number: 1
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