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

Model Number 421040

Device Problems Material Separation (1562); Delamination (2904)

Patient Problems Laceration(s) (1946); Blood Loss (2597)

Event Date 12/03/2015

Event Type  Injury  

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 report will be submitted.(b)(4).

Event Description

It was reported after four days of wear, a piece of exposed film on the skin barrier lacerated the patient's stoma.There was an unspecified amount of blood loss.The skin barrier was removed.No further patient complications were reported as a result of this event.

Manufacturer Narrative

No previous investigations are available.After a detailed batch review of the associated lot, a discrepancy was found in the record.A nonconformance (nc) was opened for the finished pack record.The nc was raised for un-welded areas in the pleated film which forms the accordion portion of the device.Suspect material was culled and destroyed.A detailed inspection sampling plan was performed by quality assurance.The re-inspection was acceptable and the material released for use.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.Reported to the fda on march 28, 2016 (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 (Section G): 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: 5315577
• MDR Text Key: 34029259
• Report Number: 1049092-2015-00725
• Device Sequence Number: 1
• Product Code: EXE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/27/2020
• Device Model Number: 421040
• Device Lot Number: 5B01793
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2015
• 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
• Patient Outcome(s): Required Intervention