MAUDE Adverse Event Report: CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C. ACTIVELIFE CONVEX ONE-PIECE PRE-CUT DRAINABLE

Model Number 125355

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

Patient Problem Pressure Sores (2326)

Event Date 05/29/2015

Event Type  Injury  

Event Description

It was reported the end user developed two open ulcerations above stoma secondary to pressure from convex skin barrier.The end user indicated the pressure is due, in part, to the placement of her stoma (directly across from her navel, in a skin fold).The end user is required to see her wound ostomy care nurse 1-2 times per week for treatment.Her treatment, included gentian violet, crusting with stomahesive powder, and aquacel ag dressing with duoderm.The ulceration have begun to heal.No further patient complications were reported as a result of this event.

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, a follow-up will be submitted.

Manufacturer Narrative

The product associated with this complaint investigation was made according to specification.After detailed batch review, no discrepancies, including non-conformances/deviations, were found.Product monitoring reviews will monitor for product trends if this issue were to reoccur.Previous applicable nonconformance(nc) investigation has been completed.The investigation revealed that 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: ACTIVELIFE CONVEX ONE-PIECE PRE-CUT DRAINABLE
• Manufacturer (Section D): CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 4917777
• MDR Text Key: 16849830
• Report Number: 1049092-2015-00398
• 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
• Report Date: 06/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/15/2020
• Device Model Number: 125355
• Device Lot Number: 5D01244
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: OSTOMY BELT; ZOLOFT; ATIVAN; EAKIN COHESIVE SEALS
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 86