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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL PROLITE MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 1000606-00
Device Problem Migration (4003)
Patient Problems Pain (1994); Hernia (2240)
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 requirements.

 
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 chronic pain, recurrent hernia, contracted and migrated mesh and revision, 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 NamePROLITE
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL
40 continental blvd
merrimack NH 03054
Manufacturer (Section G)
ATRIUM MEDICAL
40 continental blvd
merrimack NH 03054
Manufacturer Contact
40 continental blvd
merrimack, NH 03054
MDR Report Key8354455
MDR Text Key136716764
Report Number3011175548-2019-00192
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
Reporter Occupation
Type of Report Initial
Report Date 02/20/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/20/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/31/2013
Device MODEL Number1000606-00
Device Catalogue Number1000606-00
Device LOT Number10380404
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Device Age yr
Event Location No Information
Date Manufacturer Received02/05/2019
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/23/2008
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: 02/20/2019 Patient Sequence Number: 1
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