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

Model Number 022771

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

Patient Problems Itching Sensation (1943); Skin Inflammation (2443)

Event Date 08/23/2014

Event Type  Injury  

Event Description

End user reports developing a red raised bumpy sometimes itchy rash under her wafer on (b)(6) 2014.This rash is located under the mass only and does not extend to the tape collar.

Manufacturer Narrative

Based on the available info, this event is deemed a serious injury.End user reports currently applying stomahesive powder and an unk protective skin barrier wipe.End user was instructed in skin care and to continue with the crusting and if the rash does not go away to consult her physician for an antifungal powder.End user will be sent samples of the esteem plus one piece appliance.No additional pt/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.A return sample for eval is not expected.(b)(4).

Manufacturer Narrative

Additional information was received via email on september 30, 2014 providing a product lot number.Updated section with product expiration date and with device manufacture date.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.

Manufacturer Narrative

Additional information was received on september 01, 2015.No previous investigations are available.After a thorough batch review no discrepancies 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 DRAINABLE POUCH W/ STOMAHESIVE
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC, INC.; carretera sanchez, km. 18.5; 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: 4100694
• MDR Text Key: 4759771
• Report Number: 9618003-2014-00085
• 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: 08/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2014
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 84 KG