Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC INC. SUR-FIT NATURA DRAINABLE POUCH W/INVISICLOSE; 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 INC. SUR-FIT NATURA DRAINABLE POUCH W/INVISICLOSE; POUCH, COLOSTOMY Back to Search Results
Model Number 411276
Device Problem Defective Device (2588)
Patient Problem No Patient Involvement (2645)
Event Date 10/27/2014
Event Type  malfunction  
Event Description
It was reported that the film was stuck together.Based on the information received, there was no reported harm to the end user.
 
Manufacturer Narrative
Based on the available information, this event is deemed to be a reportable malfunction.Per the information received, the carton with the lot number has been discarded.No additional event details have been provided to date.Should additional information become available, a follow-up report will be submitted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SUR-FIT NATURA DRAINABLE POUCH W/INVISICLOSE
Type of Device
POUCH, COLOSTOMY
Manufacturer (Section D)
CONVATEC INC.
carretera sanchez, km. 18.5
parque industrial itabo, s.a.
haina, san cristobal 3
DR 
Manufacturer Contact
matthew walenciak,interim assoc d
211 american ave.
greensboro, NC 27409
9083779293
MDR Report Key4317032
MDR Text Key5135460
Report Number9618003-2014-00097
Device Sequence Number1
Product Code EZQ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 10/27/2014
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? Yes
Device Operator Other
Device Model Number411276
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/27/2014
Initial Date FDA Received11/19/2014
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 Unknown
Patient Sequence Number1
-
-