MAUDE Adverse Event Report: CONVATEC, INC. ACTIVELIFE 1 PC DRANABLE PUCH W/STOMAHESIVE; POUCH, COLOSTOMY

Model Number 022771

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Itching Sensation (1943); Skin Erosion (2075)

Event Date 07/29/2014

Event Type  Injury  

Event Description

It was reported by the end user of red and denuded area at 7 o'clock which measures slightly smaller than a dime.End user also reports experiencing some itching and notes a moderate amount of bleeding from the area usually when he changes his pouch every 2 days.No bleeding was noted at this time.

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.It was further reported a hernia was noted to the left side of end user's umbilicus.The end user's doctor prescribed nystatin and triamcinolone acetonide cream to the peristomal skin which did require a prescription.Current skin care consists of med-care adhesive remover, (b)(4) soap, (b)(4) powder followed by the (b)(4) protective barrier wipes, and (b)(4) paste to the peristomal skin.End user was instructed if area worsens or does not improve to call back for additional instructions.Note: the lot number provided is for the current box of pouches, not for the pouches the end user was using when he developed the skin issue.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.A return sample for evaluation is not expected.Reported to the fda on (b)(6) 2014.

Manufacturer Narrative

Additional information was received on (b)(6) 2015.No previous investigations are available.After a thorough batch review no discrepancies or non-conformances were found.There is not enough information to conclude the product did not meet specification and perform as intended.Product monitoring reviews will monitor for product trends if this issue were to reoccur.No further actions are required and the complaint will be closed.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.

• Brand Name: ACTIVELIFE 1 PC DRANABLE PUCH W/STOMAHESIVE
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC, INC.; carretera sanchez, km. 18.2; parque industrial itabo, s.a.; san cristobal, haina ; DR
• Manufacturer (Section G): CONVATEC; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: matthew walenciak ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4185161
• MDR Text Key: 16544967
• Report Number: 9618003-2014-00089
• 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,company representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/14/2019
• Device Model Number: 022771
• Device Catalogue Number: 022771
• Device Lot Number: 4F00698
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• 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: 116