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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC INC. ACTIVE LIFE PCH SM CLR 22MM; POUCH, COLOSTOMY

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CONVATEC INC. ACTIVE LIFE PCH SM CLR 22MM; POUCH, COLOSTOMY Back to Search Results
Model Number 175778
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 07/01/2014
Event Type  Injury  
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
Customer reports a small amount of blood; approximately a couple of teaspoons; appeared in her pouch.She was evaluated by her healthcare provider who recommended hydrogen peroxide to the stoma and the bleeding stopped.She said her healthcare provider did not note any cut or bruise to the stoma whatsoever.Her stoma was measured at 25 mm and it has been recommended that she use an appliance with a 25 mm opening.Customer has experienced no further episodes of bleeding since adjusting to the larger mass opening.Cwon from (b)(6) advised that her stoma measures 25 mm; and she should use a mass with opening of 25 mm.Wocn offered samples of coloplast ctf.
 
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Brand Name
ACTIVE LIFE PCH SM CLR 22MM
Type of Device
POUCH, COLOSTOMY
Manufacturer (Section D)
CONVATEC INC.
211 american ave.
greensboro NC 27409
Manufacturer Contact
jeanette johnson
211 american ave
greensboro, NC 27409
3362973009
MDR Report Key5153622
MDR Text Key28451884
Report Number1049092-2015-30550
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
Is this an Adverse Event Report? Yes
Device Operator No Information
Device Expiration Date10/03/2018
Device Model Number175778
Device Lot Number3K00396
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/15/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/04/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Weight68
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