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

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).

• 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 Key: 3667059
• MDR Text Key: 4319790
• Report Number: 9618003-2014-00019
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K833625
• Number of Events Reported: 1
• 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

• Date FDA Received: 02/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/18/2018
• Device Model Number: 022771
• Device Catalogue Number: 022771
• Device Lot Number: 3B01609
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 66