MAUDE Adverse Event Report: CONVATEC INC BARRIER AGENT

Model Number TR 104

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2018

Event Type  malfunction  

Manufacturer Narrative

Common device name - solvent, adhesive tape.(b)(6).Based on the available information, this event is deemed to be a reportable malfunction.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

It was reported ¿the bottle was too dirty when using the device.¿ photos depicting the reported complaint issue were provided by the complainant.

Event Description

To date no additional patient or event details have been received.

Manufacturer Narrative

Correction (g1) - contact office address: (b)(4).Product documentation and retain samples were examined and no anomalies were found.No sample was returned to us and without the can we are unable to provide any specific information but are only able to theorize on what may have occurred.Based on the photographic evidence it is not possible to confirm the origin of the contamination seen on the can and cap of the can.Should additional information become available, a follow up report will be submitted.Fda registration number: reporting site: 1049092.Manufacturing site: 1049092.

• Brand Name: BARRIER AGENT
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC 27409
• MDR Report Key: 8017409
• MDR Text Key: 125600591
• Report Number: 1049092-2018-00524
• Device Sequence Number: 1
• Product Code: KOX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2021
• Device Model Number: TR 104
• Device Lot Number: 18044
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1