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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3O0215 - NATURA+; POUCH, COLOSTOMY

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CONVATEC DOMINICAN REPUBLIC INC L3O0215 - NATURA+; POUCH, COLOSTOMY Back to Search Results
Model Number 416417
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Tissue Breakdown (2681)
Event Type  Injury  
Manufacturer Narrative
Initial reporter name and address: (b)(6).Contact office address: (b)(4).Based on the available information, this event is deemed to be a serious injury.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.(b)(4).
 
Event Description
The end user experienced skin breakdown that happened while she was using convatec product.The end user went to see her nurse specialized in wound, ostomy and continence (nswoc) at the time and was shown how to use silver nitrate sticks on the areas of her skin that was broken.She described these areas as ¿looked like blisters¿.The end user continued to use the product and no photo is available at this time.
 
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Brand Name
L3O0215 - NATURA+
Type of Device
POUCH, 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 Key12531570
MDR Text Key273292223
Report Number9618003-2021-02293
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,foreign
Reporter Occupation Other
Type of Report Initial
Report Date 08/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model Number416417
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/30/2021
Initial Date FDA Received09/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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