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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 30902 - PROLOOP MESH PLUG LARGE
Device Problems Material Twisted/Bent (2981); Appropriate Term/Code Not Available (3191)
Patient Problems Adhesion(s) (1695); Cyst(s) (1800); Pain (1994); Hernia (2240); Therapeutic Response, Decreased (2271)
Event Type  Injury  
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 requirement. 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, tenderness, folded mesh, hernia recurrence, adhesions, revision surgery and calcification cyst. 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.

 
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Brand NamePROLOOP MESH
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 Key10892534
MDR Text Key217922450
Report Number3011175548-2020-01397
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 11/23/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/24/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2015
Device MODEL Number30902 - PROLOOP MESH PLUG LARGE
Device Catalogue Number30902
Device LOT Number10667006
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/09/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured07/19/2010
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: 11/24/2020 Patient Sequence Number: 1
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