• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ATRIUM MEDICAL CORPORATION MESH PROLITE ULTRA SHEETS MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 30715
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Pain (1994); Fibrosis (3167); Skin Inflammation/ Irritation (4545)
Event Type  Injury  
Manufacturer Narrative
Investigation: 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. This report is based upon allegations made in a potential lawsuit in which atrium medical would be named as a defendant.
 
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. Plaintiff allegedly experienced chronic pain, perineural fibrosis, inflammation, neurectomy, lipoma and dense adhesions as a result of the implantation of the mesh implant. 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMESH PROLITE ULTRA SHEETS
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
lori gosselin
40 continental blvd
merrimack, NH 
MDR Report Key13198221
MDR Text Key283472202
Report Number3011175548-2022-00005
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 Other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/27/2021
Device Model Number30715
Device Catalogue Number30715
Device Lot Number409084
Was Device Available for Evaluation? No
Date Manufacturer Received12/17/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/28/2016
Is the Device Single Use? Yes
Type of Device Usage

Patient Treatment Data
Date Received: 01/07/2022 Patient Sequence Number: 1
-
-