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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC. ACTIVELIFE 1PC DRAINABLE POUCH W/STOMAHESIVE; POUCH, COLOSTOMY

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CONVATEC DOMINICAN REPUBLIC, INC. ACTIVELIFE 1PC DRAINABLE POUCH W/STOMAHESIVE; POUCH, COLOSTOMY Back to Search Results
Model Number 022771
Device Problem Insufficient Information (3190)
Patient Problems Itching Sensation (1943); Skin Irritation (2076); Discharge (2225)
Event Date 05/01/2013
Event Type  Injury  
Event Description
End user reported red; itchy skin beneath tape border with clear weeping at times.He stated this has been like this since (b)(6) 2013.
 
Manufacturer Narrative
No product was returned for investigation.A root cause investigation was performed for release material stuck to product on advance pouching system manual line number 1.The product retrain samples were examined and no objective evidence of any manufacturing defect or nonconformity was observed.Review of the quality systems were reviewed identifying all procedures were followed and personnel had been trained.A review of device history record for the product was analyzed and no discrepancies were noted in these records related to the complaint reported.There were no non-conformance records issued to these batches.Some simulations were conducted in order to determine the possible root cause, but the failure could not be replicated.It was determined per the investigation that the likely root cause of the complaint would be mass residue from previous product run due to ineffective line clearance or equipment cleaning on the line.Corrective/preventative actions have been initiated for the complaint issue in the capa system.No add'l pt/event details have been provided to date.Should add'l info become available an add'l follow-up report will be submitted.A return sample for eval is not expected.(b)(4).
 
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Brand Name
ACTIVELIFE 1PC DRAINABLE POUCH W/STOMAHESIVE
Type of Device
POUCH, COLOSTOMY
Manufacturer (Section D)
CONVATEC DOMINICAN REPUBLIC, INC.
carretera sanchez, km. 18.2
parque industrial itabo, s.a.
san cristobal, haina
DR 
Manufacturer (Section G)
CONVATEC DOMINICAN REPUBLIC, INC.
carretera sanchez, km. 18.2
parque industrial itabo, s.a.
san cristobal, haina
DR  
Manufacturer Contact
david gray
200 headquarters park drive
skillman, NJ 08558
9089042450
MDR Report Key3667059
MDR Text Key4319790
Report Number9618003-2014-00019
Device Sequence Number1
Product Code EZQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K833625
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 01/14/2014
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 Lay User/Patient
Device Expiration Date02/18/2018
Device Model Number022771
Device Catalogue Number022771
Device Lot Number3B01609
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/14/2014
Initial Date FDA Received02/12/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2013
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 Outcome(s) Required Intervention;
Patient Weight66
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