• 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. ACTIVE LIFE PCH STD CLR CUST; 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. ACTIVE LIFE PCH STD CLR CUST; POUCH, COLOSTOMY Back to Search Results
Model Number 022771
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Skin Tears (2516); Blood Loss (2597)
Event Date 08/04/2016
Event Type  Injury  
Manufacturer Narrative
Based on the available information, this event is deemed a serious injury.This complaint is not associated with a product malfunction.The complaint/incidence data-post market data analysis (trend analysis), clinical review, root cause analysis and risk assessment indicate a consistent rate of complaints as a result of skin complications which are caused by a variety of external factors not related to the design, materials, and/or processes of the product.No further actions are required, and this complaint will be closed.Product monitoring reviews will monitor for product trends if this issue were to reoccur.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.No patient harm was reported.Reported to the fda on: september 02, 2016.(b)(4).
 
Event Description
End user reported that while in the hospital for a leg problem, the nurse removed her pouch without using adhesive remover causing a skin tear and bleeding to an area below her stoma.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ACTIVE LIFE PCH STD CLR CUST
Type of Device
POUCH, COLOSTOMY
Manufacturer (Section D)
CONVATEC, INC.
carretera sanchez, km. 18.5
parque industrial itabo, s.a.
haina, san cristobal 33102
DR  33102
Manufacturer Contact
jeanette johnson
7900 triad center drive
suite 400
greensboro, NC 27409
3365424681
MDR Report Key5926288
MDR Text Key53854269
Report Number9618003-2016-00043
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 Other
Type of Report Initial
Report Date 08/11/2016
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 Number022771
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/11/2016
Initial Date FDA Received09/02/2016
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 Age56 YR
Patient Weight77
-
-