• 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 ACTIVELIFE; 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 ACTIVELIFE; POUCH, COLOSTOMY Back to Search Results
Model Number 175779
Device Problem Malposition of Device (2616)
Patient Problem Skin Irritation (2076)
Event Type  malfunction  
Manufacturer Narrative
(b)(6).Based on the available information, this event is deemed to be a reportable malfunction.No lot number is available.A detailed investigation or batch review cannot be conducted.  therefore, this evaluation will be closed.  this issue will be monitored through the post market product monitoring review process.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).
 
Event Description
It was reported the starter hole was off center in 16 wafers.Due to frequent leakage and changing, the end user reports her skin became irritated.No medical treatment to date has been provided.No photo was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ACTIVELIFE
Type of Device
POUCH, 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
jeanette johnson
7900 triad center drive
suite 400
greensboro, NC 27409
MDR Report Key8132550
MDR Text Key129345639
Report Number9618003-2018-03831
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 Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number175779
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/16/2018
Initial Date FDA Received12/05/2018
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
-
-