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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 Malposition of Device (2616)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Device 2 of 3.(b)(6).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
It was reported that the wafer came with off centered starter hole.The product was not used.No photo is available at this time.
 
Event Description
To date no additional patient or event details have been received.
 
Manufacturer Narrative
(b)(6).This complaint has been reported as type 2.No samples or photos were received for analysis and investigation; for that reason, the malfunction reported by the customer could not be confirmed.On 10/may/2021, a batch record review was performed for lot 0h04069.Lot 0h04069 was manufactured on 8/29/2020 in the convex one piece line, with a total of 2,016 mku.Based on the review carried out, all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bom, sap material 1703552, icc code 416742 and manufacturing order 1540669.The process was run according to process instruction pi21-076, documented in the mr21-076.Batch record review carried out supports that no issues related to the problem were identified.In addition, a complaint search for lot 0h04069 and malfunction code 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 trend for this lot is observed.As per complaint manufacturing investigation procedure wi-0359, version 5.0, it is not required to open a nonconformance report (ncr) for type 2 complaints which were not confirmed (either by photos or samples provided by the customers or results of the batch record review) and no potential trend is identified.Therefore, for all explained above, no additional action is required and this complaint 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: 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
MDR Report Key11342070
MDR Text Key232332816
Report Number9618003-2021-00247
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 distributor,foreign
Type of Report Initial,Followup
Report Date 01/25/2021
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 Other
Device Model Number416742
Device Lot Number0H04069
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 01/25/2021
Initial Date FDA Received02/18/2021
Supplement Dates Manufacturer Received05/10/2021
Supplement Dates FDA Received07/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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