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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 413522
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Hemorrhage/Bleeding (1888); Skin Inflammation/ Irritation (4545)
Event Type  Injury  
Event Description
The end user reported that most of the appliances were used from twenty appliances out of two boxes of ten appliances each from an unknown lot number. She experienced skin irritation and saw the wound center next day's morning. She also stated that she has raised areas around her stoma which sometimes minimally bleed, and the frequent appliance changes led to bleeding of noted areas. Therefore, consumer was treated with silver nitrate by the wound center. She did not take blood thinners. She discontinued the product and was currently using a two-piece competitor appliance and had previously obtained a three-day wear time. She had an ileostomy in (b)(6) 2021 and has a reversal planned for on (b)(6) 2022. No photo is available at this time.
 
Manufacturer Narrative
Device 14 of 20. The product malfunction for the reported event is considered as unclear since end user experienced more frequent changes, and it was unclear why the end user was changing so often as per the information provided. Based on the available information, this event is deemed to be a serious injury. 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).
 
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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 Key14249109
MDR Text Key290371293
Report Number9618003-2022-00536
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 04/07/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number413522
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/07/2022
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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