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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 Problems Laceration(s) (1946); Pain (1994); Discomfort (2330); Tissue Breakdown (2681)
Event Type  malfunction  
Manufacturer Narrative
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).
 
Event Description
The end user applied 1 out of box of 10 wafers and it caused pain to the stoma. She further stated that "when cutting wafer, some sharp edges were left, which cut a bit into her stoma" (possibly resulting in pain/discomfort). She was not cutting beyond the cutting guide. The sharp edges were after the wafer was cut. Reportedly, the pouch was not the correct size for her stoma. The end user continued to use the product. No photo available is available at this time.
 
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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 Key12622471
MDR Text Key281432459
Report Number9618003-2021-02570
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 09/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number022771
Device Lot Number9F02271
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Manufacturer Received12/02/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/20/2019
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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