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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
Model Number 1000606-00
Device Problems Entrapment of Device (1212); Difficult to Remove (1528)
Patient Problems Adhesion(s) (1695); Pain (1994)
Event Type  Injury  
Manufacturer Narrative
A follow up report will be submitted on the completion of the investigation into this event. This report is based upon allegations made in a potential lawsuit in which atrium medical would be named as a defendant. This report shall not be considered as an admission by atrium medical that the product described in the pre-suit claim and described herein is or was defective, or that it had any causal relationship to any injuries allegedly suffered by the claimant.
 
Event Description
This event is deemed reportable based on the allegations in a potential lawsuit which, while unsubstantiated, suggest that a reportable event may have occurred during use of an atrium medical mesh product. Allegedly, four months after mesh being implanted to repair a ventral hernia the patient developed bronchitis and noticed a lot of pain the area of the hernia repair when she coughed. Allegedly, surgeon could not remove all of the mesh due to adhesions. Since this is a potential 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
A review of the manufacturing lot history and sterilization records was conducted. All in-process specifications and release criteria were met.
 
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Brand NamePROLITE MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
hudson NH 03051
Manufacturer (Section G)
ATRIUM MEDICAL CORP.
5 wentworth drive
5 wentworth drive
hudson NH 03051
Manufacturer Contact
theresa morin
40 continental blvd.
merrimack, NH 03054
6038645237
MDR Report Key6412562
MDR Text Key70174771
Report Number1219977-2017-00038
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K002093
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 03/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2010
Device Model Number1000606-00
Device Catalogue Number1000606-00
Device Lot Number10019056
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/28/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/27/2005
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: 03/17/2017 Patient Sequence Number: 1
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