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

Model Number 413179

Device Problem Insufficient Information (3190)

Patient Problems Itching Sensation (1943); Swelling (2091); Hernia (2240)

Event Date 12/19/2013

Event Type  Injury  

Event Description

End user reported he has raised red areas like pimples around tape border; states itches; no drainage; all beneath tape border, but more on the right side than left.He also reported that he has a hernia and uses a belt.

Manufacturer Narrative

Based on the available information, this event is deemed a serious injury.The end user reports that he changes wafer every seven days.It was recommended that the end user uses one piece for hernia.The end user reported he uses kenalog and nystop.He stated kenalog spray seems to make it a little better.No additional patient/event details have been provided to date.A return sample for evaluation is not expected.Should additional information becomes available, a follow-up report will be submitted.

Manufacturer Narrative

The product associated with batch 3a01097 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.Reported to the fda on (b)(6) 2016.(b)(4).

• Brand Name: SUR-FIT NATURA 2PC DURAHESIVE CONVEX 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: 3597023
• MDR Text Key: 16684795
• Report Number: 1049092-2014-00039
• 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: 12/26/2013

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: 01/10/2018
• Device Model Number: 413179
• Device Catalogue Number: 413179
• Device Lot Number: 3A01097
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/26/2013
• Initial Date FDA Received: 01/21/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2013
• 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 Outcome(s): Required Intervention
• Patient Weight: 73