• 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 CORP ATRIUM C-QUR MESH HERNIA MESH 8.9CM X 8.9CM 3 1/2IN X 3 1/2 IN

  • 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 CORP ATRIUM C-QUR MESH HERNIA MESH 8.9CM X 8.9CM 3 1/2IN X 3 1/2 IN Back to Search Results
Catalog Number 31543
Event Date 06/06/2012
Event Type  Injury  
Event Description

Reporter had hernia repair with this device. (b)(6) days later, he removed the bandage to take a shower and his skin looked sunburned, swollen and there was a yellow discharge. Hospital said it was infected. He had the mesh removed, given antibiotics, had drains placed. Reporter was in the hospital a total of five days. He then began vomiting after discharge on (b)(6) 2012 and was found to have an obstruction. Reporter was taken back to surgery on (b)(6) 2012 and the obstruction was relieved. Reporter says he has heard of many people complaining about these meshes. He has tried to contact the mfr, but they have not called him back. The physician said that the mesh was infected and reporter feels that if he wasn't as strong as he was, he would not have made it.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameATRIUM C-QUR MESH
Type of DeviceHERNIA MESH 8.9CM X 8.9CM 3 1/2IN X 3 1/2 IN
Manufacturer (Section D)
ATRIUM MEDICAL CORP
MDR Report Key2639496
Report NumberMW5025995
Device Sequence Number1
Product CodeFTM
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/29/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/29/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date01/01/2015
Device Catalogue Number31543
Device LOT Number10820946055
OTHER Device ID Number0100650862315431
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 06/29/2012 Patient Sequence Number: 1
-
-