MAUDE Adverse Event Report: CONVATEC INC. ESTEEM + CONVEX ONE-PIECE DRAINABLE PRE-CUT P; POUCH, COLOSTOMY

Model Number 416745

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

Patient Problems Itching Sensation (1943); Rash (2033)

Event Type  Injury  

Event Description

It was reported the end user developed an itchy, intact rash under the tape collar and mass of the skin barrier.The end user indicated her usual device wear time is approximately 2 days.As the rash has persisted for "several years", the patient consulted her physician and was prescribed an anti-fungal powder (nystatin).No further information was provided.

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.No additional patient/event details have been provided to date.Should additional information become available, follow-up report will be submitted.

Manufacturer Narrative

The product associated with batch 4m01827 was made according to specification.After detailed batch review, no discrepancies (includes non-conformances/deviations) 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.Previous investigation, is applicable to this complaint investigation.This previous investigation is open.Therefore, this complaint will remain open until completion of the previous investigation.On december 30, 2015 it was noted that previous nc is applicable to this complaint and is closed.No further actions are required, and this 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.(b)(4).

Manufacturer Narrative

Corrected data: investigation results were omitted from mdr mfr # 1049092-2015-00266 submitted on january 12, 2016.Investigation results were received on december 30, 2015 and are as follows: the complaint/incidence data-post market data analysis (trend analysis), clinical review, root cause analysis and risk assessment indicate a consistent rate of complaints by the end user as a result of skin complications 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.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).

• Brand Name: ESTEEM + CONVEX ONE-PIECE DRAINABLE PRE-CUT P
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american ave.; greensboro NC 27409
• Manufacturer (Section G): CONVATEC GLOBAL QARAC HEAD QUARTERS; 7900 triad center drive; suite 400; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 4790397
• MDR Text Key: 5853998
• Report Number: 1049092-2015-00266
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2015

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 Date: 12/17/2019
• Device Model Number: 416745
• Device Lot Number: 4M01827
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/12/2015
• Initial Date FDA Received: 05/21/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/12/2016; 01/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: EAKIN SEAL; (UNKNOWN) BARRIER WIPE
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 58