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. ACTIVELIFE ONE-PIECE DRAINABLE POUCH; 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. ACTIVELIFE ONE-PIECE DRAINABLE POUCH; POUCH, COLOSTOMY Back to Search Results
Model Number 400598
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Irritation (2076)
Event Date 09/01/2014
Event Type  Injury  
Event Description
End user reports since september of last year she has had peristomal irritation to 6 o'clock area.End user further states that 3 weeks ago a wound doctor began silver nitrate treatments.
 
Manufacturer Narrative
Based on the available information, this event is deemed to be a serious injury.No additional patient/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.(b)(6).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ACTIVELIFE ONE-PIECE DRAINABLE POUCH
Type of Device
POUCH, COLOSTOMY
Manufacturer (Section D)
CONVATEC INC.
carretera sanchez, km. 1.5
parque industrial itabo, s.a.
san cristobal
DR 
Manufacturer Contact
matthew walenciak, director
211 american ave
greensboro, NC 27409
9083779293
MDR Report Key4870682
MDR Text Key5867137
Report Number9618003-2015-00032
Device Sequence Number1
Product Code EZQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 06/19/2015
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 Lay User/Patient
Device Model Number400598
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/19/2015
Initial Date FDA Received06/25/2015
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
Patient Outcome(s) Required Intervention;
Patient Weight82
-
-