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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3O0100 - ACTIVE LIFE POUCH, COLOSTOMY

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CONVATEC DOMINICAN REPUBLIC INC L3O0100 - ACTIVE LIFE POUCH, COLOSTOMY Back to Search Results
Model Number 022771
Device Problem Sharp Edges (4013)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
The end user reported that the tail closure felt rough and surmised that there had been a change in the clip closures that was snagging the pouch film. They were much more difficult to open and close than they used to be and the force needed to open and close might perhaps contributing to the issue. There was no harm reported. No photo is available at this time.
 
Manufacturer Narrative
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).
 
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Brand NameL3O0100 - ACTIVE LIFE
Type of DevicePOUCH, COLOSTOMY
Manufacturer (Section D)
CONVATEC DOMINICAN REPUBLIC INC
km 18.5 parque industrial
itabo, s.a. haina
san cristobal 91000
DR 91000
Manufacturer (Section G)
CONVATEC DOMINICAN REPUBLIC INC
km 18.5 parque industrial
itabo, s.a. haina
san cristobal 91000
DR 91000
Manufacturer Contact
pamela meadows
7815 national service road
suite 600
greensboro, NC 
3365424679
MDR Report Key14390047
MDR Text Key291635977
Report Number9618003-2022-00547
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
Report Date 04/20/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number022771
Device Lot Number1J01506
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/20/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/17/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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