MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE SIZE 4

Model Number	IPN047595
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn#: (b)(4).
Event or Problem Description
Complaint from medwatch: it was reported "teleflex lma became separated during extubation.Tube removed and cuff became dislodged in patient airway.Patient had to be paralyzed, open jaw and manually remove cuff".No patient injury, harm, or desaturation reported.Patient condition unknown at time of report.
Additional Manufacturer Narrative
(b)(4) complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
Complaint from medwatch: it was reported "teleflex lma became separated during extubation.Tube removed and cuff became dislodged in patient airway.Patient had to be paralyzed, open jaw and manually remove cuff".No patient injury, harm, or desaturation reported.Patient condition unknown at time of report.

• Brand Name: LMA UNIQUE SIZE 4
• Common Device Name: LMA UNIQUE
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 11345711
• Report Number: 9681900-2021-00005
• Device Sequence Number: 729516
• Product Code: CAE
• UDI-Device Identifier: 15060112314718
• UDI-Public: 15060112314718
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2021

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: No Information
• Device Expiration Date: 06/28/2022
• Device Model Number: IPN047595
• Device Catalogue Number: 125040
• Device Lot Number: PMBPL2
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 03/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED; NONE REPORTED
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention