MAUDE Adverse Event Report: COVIDIEN SHILEY; LOW PRESSURE CUFFED 4-8.5 BX1

Model Number	4LPC
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/19/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The customer did not retain the lot number.The date of manufacture cannot be determined.
Event or Problem Description
The report received stated the customer noticed when the patient was post-operative liquid had entered the inflation balloon.The tube was removed and replaced.There was no injury to patient.The tube was checked prior to use.

• Brand Name: SHILEY
• Common Device Name: LOW PRESSURE CUFFED 4-8.5 BX1
• Manufacturer (Section D): COVIDIEN; avenida henequen; 1181 parque industrial salvarcar; cd. juarez, chihuahua ; MX
• MDR Report Key: 5641942
• Report Number: 2936999-2016-00393
• Device Sequence Number: 10820654
• Product Code: JOH
• UDI-Device Identifier: 60884522007127
• UDI-Public: 60884522007127
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K962173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/20/2016

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4LPC
• Device Catalogue Number: 4LPC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2016
• Initial Report FDA Received Date: 05/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Weight: 59