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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC DOM. REPUBLIC ESTEEM PCH CLD WF STDTAN 60/70MM; POUCH, COLOSTOMY
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CONVATEC DOM. REPUBLIC ESTEEM PCH CLD WF STDTAN 60/70MM; POUCH, COLOSTOMY Back to Search Results
Model Number 416701
Device Problems Material Disintegration (1177); Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/20/2014
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).
 
Event Description
End user reports changes pouch three times a day.Reports stomahesive shreds and is hard to remove even with adhesive remover.Uses sensicare skin protectant barrier wipes.Reports when product delivered boxes were warm to touch.
 
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Brand Name
ESTEEM PCH CLD WF STDTAN 60/70MM
Type of Device
POUCH, COLOSTOMY
Manufacturer (Section D)
CONVATEC DOM. REPUBLIC
inc.: carr. sanchez, km. 18.5
parque industrial, haina
san cristobal, 33102
DR  33102
Manufacturer Contact
jeanette johnson
211 american ave
greensboro, NC 27409
3362973009
MDR Report Key5154347
MDR Text Key28445124
Report Number9618003-2015-30598
Device Sequence Number1
Product Code EZQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Report Date 02/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2015
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date07/11/2019
Device Model Number416701
Device Lot Number4G00844
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received02/27/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/12/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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