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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC DOM. REPUBLIC INC ACTIVE LIFE PCH STD TAN 32MM; POUCH, COLOSTOMY

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CONVATEC DOM. REPUBLIC INC ACTIVE LIFE PCH STD TAN 32MM; POUCH, COLOSTOMY Back to Search Results
Model Number 022759
Device Problem Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Convatec is submitting this report as a result of activities related to convatec remediation protocol (b)(4).Convatec is submitting this report pursuant to the provisions of 21cfr part 803.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).
 
Event Description
It was reported that mass and tape collar both difficult to remove after 4 days of wear-off and on in last year.Use of appropriate product/accessory product discussed.
 
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Brand Name
ACTIVE LIFE PCH STD TAN 32MM
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
7900 triad center drive
greensboro, NC 27409
3365424681
MDR Report Key5289433
MDR Text Key33276321
Report Number9618003-2015-40099
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
Type of Report Initial
Report Date 11/06/2015
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 Number022759
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/06/2015
Initial Date FDA Received12/11/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
IBUPROFEN METFORMIN,
Patient Weight100
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