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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 421621
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Burning Sensation (2146); Contact Dermatitis (4546)
Event Type  Injury  
Manufacturer Narrative
Common device name: pouch, colostomy.Contact office address: dr.(b)(6).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).
 
Event Description
The end user tried a sample product, which aggravated the pre-existing symptoms of burning, itching and the red skin condition started happening "all over my body".After a few hours, she went to the emergency room.She was diagnosed with contact dermatitis, was started on prednisone and was referred to an allergy doctor.The allergist prescribed an antihistamine (brand unknown) and topical cream to be used on the peristomal skin (brand unknown).The consumer left her pouch off for several days so that the cream could be applied.Thereafter, she was wore a non-company product and her skin was slowly improving.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
7900 triad center drive
suite 400
greensboro, NC 
3365424681
MDR Report Key11804770
MDR Text Key264774590
Report Number1049092-2021-00069
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 04/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model Number421621
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/14/2021
Initial Date FDA Received05/11/2021
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 Age57
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