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U.S. Department of Health and Human Services

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

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CONVATEC DOMINICAN REPUBLIC INC ACTIVELIFE POUCH, COLOSTOMY Back to Search Results
Model Number 022765
Device Problems Malposition of Device (2616); Positioning Problem (3009)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Device 17 of 17. 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 17 wafers from two boxes with the same lot number had off-centered starter hole. Out of these, 12 wafers were unused. The remaining 5 wafers were used and the end user experienced reduced wear time with these. No photo is available at this time.
 
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Brand NameACTIVELIFE
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
jeanette johnson
7900 triad center drive
suite 400
greensboro, NC 27409
3365424681
MDR Report Key9456860
MDR Text Key177602864
Report Number9618003-2019-17383
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
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model Number022765
Device Lot Number9G04454
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/03/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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