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

MAUDE Adverse Event Report: COLOPLAST MANUFACTURING US, LLC EXAIR ANTERIOR KIT; SURGICAL MESH

  • 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
 

COLOPLAST MANUFACTURING US, LLC EXAIR ANTERIOR KIT; SURGICAL MESH Back to Search Results
Model Number 5010001022
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Discharge (2225); Prolapse (2475)
Event Type  Injury  
Manufacturer Narrative
Coloplast has not been provided any corroborating evidence to verify the information contained in this report.(b)(4).
 
Event Description
As reported to coloplast though not verified, patient's legal representative stated mesh erosion, foul smelling discharge, and recurrent prolapse.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EXAIR ANTERIOR KIT
Type of Device
SURGICAL MESH
Manufacturer (Section D)
COLOPLAST MANUFACTURING US, LLC
1601 west river road north
minneapolis MN 55411
Manufacturer (Section G)
COLOPLAST MANUFACTURING US, LLC
1601 west river road north
minneapolis MN 55411
Manufacturer Contact
christine buckvold
1601 west river road north
minneapolis, MN 55411
6123024982
MDR Report Key6189685
MDR Text Key62846685
Report Number2125050-2016-00388
Device Sequence Number1
Product Code OTP
Combination Product (y/n)N
PMA/PMN Number
K112386
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial
Report Date 12/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Model Number5010001022
Device Catalogue Number5010001022
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/01/2016
Initial Date FDA Received12/20/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age53 YR
-
-