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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 175778
Device Problem Sharp Edges (4013)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
The end user reported that sharp plastic piece was poking through convex portion of pouch. She stated that she saw the defect prior and did not use the product. No photo is available at this time.
 
Manufacturer Narrative
Correction - contact office address: (b)(4). 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 Key12874045
MDR Text Key285234494
Report Number9618003-2021-02688
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,Followup
Report Date 11/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number175778
Device Lot Number1C04480
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Manufacturer Received11/26/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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