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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORPORATION PROLOOP MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 30901
Device Problem Material Separation (1562)
Patient Problems Adhesion(s) (1695); Pain (1994); Hernia (2240)
Event Type  Injury  
Manufacturer Narrative

We are unable to fully investigate this event as no product code, lot number, or sample was provided. Device evaluated by manufacturer? not returned.

 
Event Description

This event is deemed reportable based on the allegations in a lawsuit which, while unsubstantiated, suggest that a reportable event may have occurred during use of atrium medical¿s mesh product. Plaintiff allegedly experienced pain and discomfort, mesh separation, recurrent hernia, mesh contraction, adhesions, seroma, risk and anxiety of surgery, and related sequelae. Since this is a legal matter, the case has been turned over to legal counsel and further information obtained through investigation or discovery may fall under the attorney/client and/or work product privilege. However, atrium will supplement this report as appropriate if additional information comes to its attention.

 
Manufacturer Narrative

Based on the review of the device history records and product complaint details atrium can find no fault with the product. This lot of mesh passed all quality and performance requirements.

 
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Brand NamePROLOOP 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 Key9260332
MDR Text Key164428214
Report Number3011175548-2019-01140
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,Followup
Report Date 10/31/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/31/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number30901
Device Catalogue Number30901
Device LOT Number408278
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/26/2019
Was Device Evaluated By Manufacturer? No
Date Device Manufactured09/09/2016
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: 10/31/2019 Patient Sequence Number: 1
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