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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 416740
Device Problem Malposition of Device (2616)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
(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's daughter reported that the pre-cut hole of 1 appliance was off centered and misshappened.The product was not used and no photo is available at this time.
 
Event Description
To date no additional patient or event details have been received.
 
Manufacturer Narrative
(b)(6).Batch record review results: lot 0j00168 was manufactured on 09/06/2020 in the cvx1pc manufacturing line, with a total of (b)(4) mkus.On 19/aug/2021, a batch record review was performed to verify if all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bom.No issues related to the defect were found in the documentation.On 19/aug/2021 a complaint search for lot 0j00168 and malfunction code ost-pmc1.8 / ost-pmc01.08 skin barrier starter hole is defective (e.G misalignment or off center), leakage may occur (pre-cut only) was carried out and as a result, no additional complaints were found; therefore, no potential trend is observed.Should additional information become available, a follow up report will be submitted.Fda registration number: reporting site: 1049092.Manufacturing site: 9618003.
 
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Brand Name
L3O0675 - ESTEEM+
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
MDR Report Key12286542
MDR Text Key265338187
Report Number9618003-2021-01664
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 other
Type of Report Initial,Followup
Report Date 07/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number416740
Device Lot Number0J00168
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 07/20/2021
Initial Date FDA Received08/06/2021
Supplement Dates Manufacturer Received08/19/2021
Supplement Dates FDA Received08/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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