MAUDE Adverse Event Report: CONVATEC INC. ACTIVELIFE 1 PC - UROSTOMY CONVEX POUCH W/DH; URINARY, ILEOSTOMY 78 EXH

Model Number 125366

Device Problem Increased Sensitivity (2535)

Patient Problem Skin Inflammation (2443)

Event Date 05/28/2014

Event Type  Injury  

Event Description

It is reported that the end-user developed red areas with healing pimples beneath mass and outside of mass extending out from mass approximately two (2) inches and traveling down to groin of the ostomy device.It is further reported end-user was provided prescription diflucan and prescription nystop powder to treat these affected areas.

Manufacturer Narrative

Based on the available info, this event is deemed to be a serious injury based on the pt requiring prescription diflucan and prescription nystop powder.In addition, end-user performed skin prep; applied athletes foot powder and tinactin for treatment.No additional patient/event details have been provided to date.A return sample for evaluation is not expected.Should additional info become available, a follow-up report will be submitted.Convatec will continue to track and monitor such complainants according to convatec inc's.Complaint handling and capa procedures.

Manufacturer Narrative

Corrected data: the following conclusions codes were previously omitted or reported in error on the initial mdr, mfr #: 1049092-2014-00264, reported to the fda on july 02, 2014: (b)(4).The product associated with batch (b)(4) was made according to specification.After detailed batch review, no discrepancies (includes non-conformances/deviations) were found.This complaint is not associated with a product malfunction.The complaint/incidence data-post market data analysis (trend analysis), clinical review, root cause analysis and risk assessment indicate a consistent rate of complaints as a result of skin complications which are caused by a variety of external factors not related to the design, materials, and/or processes of the product.No further actions are required, and this complaint will be closed.Product monitoring reviews will monitor for product trends if this issue were to reoccur.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.Reported to the fda on march 30, 2016, (b)(4).

• Brand Name: ACTIVELIFE 1 PC - UROSTOMY CONVEX POUCH W/DH
• Type of Device: URINARY, ILEOSTOMY 78 EXH
• Manufacturer (Section D): CONVATEC INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 4009791
• MDR Text Key: 4954569
• Report Number: 1049092-2014-00264
• Device Sequence Number: 1
• Product Code: EXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K780454
• 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,Followup
• Report Date: 06/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/21/2018
• Device Model Number: 125366
• Device Catalogue Number: 125366
• Device Lot Number: 3L01276
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 93