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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 413312
Device Problem Sharp Edges (4013)
Patient Problems Tissue Breakdown (2681); Blister (4537)
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
The end user reported open and chronic blister from where the sharp edge of the invisiclose rubbed against her leg repeatedly. She currently had no blister. She self-treated with bacitracin and a band-aid and it resolved without medical intervention. She could not provide more specific information as this was not a recent occurrence. She figured out to slightly angle the pouch to prevent this occurrence and continued to 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. 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
The end user reported open and chronic blister from where the sharp edge of the invisiclose rubbed against her leg repeatedly. She currently had no blister. She self-treated with bacitracin and a band-aid and it resolved without medical intervention. She could not provide more specific information as this was not a recent occurrence. She figured out to slightly angle the pouch to prevent this occurrence and continued to use the product. 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 Key13091797
MDR Text Key285955552
Report Number9618003-2021-02766
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 11/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number413312
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/30/2021
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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