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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3O0200 - NATURA POUCH, COLOSTOMY

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CONVATEC DOMINICAN REPUBLIC INC L3O0200 - NATURA POUCH, COLOSTOMY Back to Search Results
Model Number 420696
Device Problem Material Too Rigid or Stiff (1544)
Patient Problem Tissue Breakdown (2681)
Event Type  malfunction  
Manufacturer Narrative
Correction - contact office address: (b)(4). Based on the available information, this event is deemed to be a reportable malfunction. This complaint has been evaluated. No lot number is available. A detailed investigation or batch review cannot be conducted. Therefore, this evaluation will be closed. This issue will be monitored through the post market product monitoring review process. To date no additional information has been received. Should additional information become available, a follow-up report will be submitted. Fda registration number (b)(4).
 
Event Description
End user stated that tap of one pouch was hard and dug into her skin. No open areas were reported and there was no leakage involved. Wear time was not provided. She discontinued the product and was wearing another product and the issue was resolved. No photo is available at this time.
 
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Brand NameL3O0200 - NATURA
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 Key12982220
MDR Text Key285822594
Report Number9618003-2021-02761
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 11/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number420696
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/15/2021
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 Unkown

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