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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC INC L3O0675 - ESTEEM+

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CONVATEC INC L3O0675 - ESTEEM+ Back to Search Results
Model Number 421623
Device Problem Sharp Edges (4013)
Patient Problem Hemorrhage/Bleeding (1888)
Event Type  malfunction  
Manufacturer Narrative
Common device name: pouch, colostomy.Mfr site: (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.(b)(4).
 
Event Description
The end user reported that his wear time was 3 days but he wanted to return to 4-5 days.When the end user had cut the wafer stoma opening, it was jagged and this resulted in bleeding to the peristomal skin or the stoma.The blood did collect in the pouch.He spoke with his doctor regarding the issue and the doctor gave him an over the counter spray (name unknown) to use.The end user continued to use the product.He was unable to say if he had used non-convex product before.He was unable to verify stoma size but previous documentation was 40mm.No photo is available at this time.
 
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Brand Name
L3O0675 - ESTEEM+
Manufacturer (Section D)
CONVATEC INC
211 american avenue
greensboro NC
Manufacturer (Section G)
CONVATEC INC
211 american avenue
greensboro NC
Manufacturer Contact
pamela meadows
7815 national service road
suite 600
greensboro, NC 
3365424679
MDR Report Key12195653
MDR Text Key262482801
Report Number1049092-2021-00079
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 Other
Type of Report Initial
Report Date 06/23/2021
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 Number421623
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/23/2021
Initial Date FDA Received07/20/2021
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age73
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