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

MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC ESTEEM + POUCH, COLOSTOMY

  • 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
 

CONVATEC DOMINICAN REPUBLIC INC ESTEEM + POUCH, COLOSTOMY Back to Search Results
Model Number 416747
Device Problem Sharp Edges (4013)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Device 9 of 12. (b)(6). Based on the available information, this event is deemed to be a reportable malfunction. To date no additional information has been received. Should additional information become available, a follow-up report will be submitted. (b)(4).
 
Event Description
The end user reported that the pre-cut hole in 40 percent of the boxes had irregularities (jaggered edges) that were rough on the skin. The end user had used the affected products and there was no harm reported. No photo is available at this time.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameESTEEM +
Type of DevicePOUCH, COLOSTOMY
Manufacturer (Section D)
CONVATEC DOMINICAN REPUBLIC INC
km 18.5 parque industrial
itabo, s.a. haina
san cristobal
Manufacturer (Section G)
CONVATEC DOMINICAN REPUBLIC INC
km 18.5 parque industrial
itabo, s.a. haina
san cristobal
Manufacturer Contact
pamela meadows
7900 triad center drive
suite 400
greensboro, NC 27409
3365424681
MDR Report Key10647438
MDR Text Key210381313
Report Number9618003-2020-14682
Device Sequence Number1
Product Code EZQ
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number416747
Device Lot Number0E02473
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received04/04/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/24/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-