MAUDE Adverse Event Report: CONVATEC INC. NATURA MOLDABLE DURAHESIVE SKIN BARRIER; PROTECTOR, OSTOMY

Model Number 411802

Device Problem Difficult to Remove (1528)

Patient Problem Tissue Damage (2104)

Event Type  malfunction  

Manufacturer Narrative

Height: (b)(6).Based on the available information, this event is deemed to be a reportable malfunction.No lot number or sample is available for evaluation.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).

Event Description

It was reported by the end user that the mass adheres to her skin so much that she strips her skin when she removes the wafer.These areas measure approximately 3mm in size.

Manufacturer Narrative

This supplemental report is being submitted to correct conclusion code which was used in error on the initial mdr submitted on june 01, 2016.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: NATURA MOLDABLE DURAHESIVE SKIN BARRIER
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5693526
• MDR Text Key: 46360334
• Report Number: 1049092-2016-00251
• Device Sequence Number: 1
• Product Code: EXE
• 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
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 05/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 411802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/06/2016
• 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
• Patient Age: 68 YR
• Patient Weight: 73