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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3O0675 - ESTEEM+ POUCH, COLOSTOMY

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CONVATEC DOMINICAN REPUBLIC INC L3O0675 - ESTEEM+ POUCH, COLOSTOMY Back to Search Results
Model Number 416742
Device Problem Sharp Edges (4013)
Patient Problem Itching Sensation (1943)
Event Date 09/27/2021
Event Type  malfunction  
Manufacturer Narrative
Correction - contact office address: (b)(6). 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 reporting site: (b)(4). Manufacturing site: (b)(4).
 
Event Description
On (b)(6) 2021, the end user reported that she tried one wafer with pre-cut opening 25-mm but she stated that her stoma was also 25-mm and it rubbed against the wafer opening which she described as rough and she felt intermittent scratchiness. She could not say if the scratchiness was on the stoma or on the peristomal skin. No cuts, scrapes, or scratches was reported by end user. There was no leakage noted and the end user continued to use the product. No photo is available at this time.
 
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Brand NameL3O0675 - ESTEEM+
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 Key12655619
MDR Text Key278159028
Report Number9618003-2021-02572
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 09/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number416742
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/27/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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