• 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

  • 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 Back to Search Results
Model Number 5014502400
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Pain (1994); Pocket Erosion (2013); Skin Erosion (2075); Urinary Tract Infection (2120); Prolapse (2475); Urinary Incontinence (4572)
Event Type  Injury  
Manufacturer Narrative
This event was previously reported under manufacturer report number 2125050-2020-00531. This report is intended to be a follow-up report to submit additional information that has been received. Any further information warranting a follow-up report will be submitted under this new manufacturer report number. (b)(4). Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
 
Event Description
Additional information received, as reported to coloplast though not verified, states patient has severe abdominal pain and right side pain. Right back/hip pain and left thigh pain. Sling excision and vaginal mesh excision was performed on (b)(6) 2020.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Manufacturer (Section G)
COLOPLAST MANUFACTURING US, LLC
1601 west river road north
minneapolis MN 55411
Manufacturer Contact
usaby angela kilian
1601 west river road north
minneapolis, MN 55411
8007880293
MDR Report Key11887054
MDR Text Key252909595
Report Number2125050-2021-00640
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 10/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number5014502400
Device Lot Number6381389
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/19/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

-
-