MAUDE Adverse Event Report: CONVATEC INC. SUR-FIT NATURA 2PC DURAHESIVE MOLDABLE WAFER ; PROTECTOR, OSTOMY

Model Number 411806

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Itching Sensation (1943)

Event Date 12/05/2013

Event Type  Injury  

Event Description

End user reported that he applied product of durahesive moldable sent for trial and noticed redness and itchy sensation under tape border.

Manufacturer Narrative

Based on the available info, this event is deemed a serious injury.The end user removed the product and applied a hollister product.End user reports that his skin is improving.The use of accessory products was discussed with the end user.No additional pt/event details have been provided to date.A return sample for evaluation is not expected.Should additional information become available, a follow-up report will be submitted.(b)(4).

Manufacturer Narrative

The product associated with batch 3h02271 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.

• Brand Name: SUR-FIT NATURA 2PC DURAHESIVE MOLDABLE WAFER
• Type of Device: PROTECTOR, OSTOMY
• 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: 3571130
• MDR Text Key: 4218925
• Report Number: 1049092-2014-00005
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K855018
• 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: 12/05/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 411806
• Device Catalogue Number: 411806
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/29/2016
• 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 Weight: 107