MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA CLASSIC, REU, SIZE 4 (100040)

Model Number	IPN900275
Medical Device Problem Code	Dent in Material (2526)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "slight herniation of the cuff, the physician reported she did not feel it sealed that well".No patient involvement reported.
Additional Manufacturer Narrative
(b)(4).The actual sample was not returned; however, the customer provided a photo for evaluation.The manufacturing site has reviewed the photo and confirmed that the cuff was deformed.Although the complaint was confirmed, a root cause could not be determined without the actual sample to evaluate.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
It was reported "slight herniation of the cuff, the physician reported she did not feel it sealed that well".No patient involvement reported.

• Brand Name: LMA CLASSIC, REU, SIZE 4 (100040)
• Common Device Name: LMA CLASSIC
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): THE LARYNGEAL MASK COMPANY; 6 battery road #07-02; singapore 04990 9; SN 049909
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 13738996
• Report Number: 9681900-2022-00012
• Device Sequence Number: 4607972
• Product Code: CAE
• UDI-Device Identifier: 14026704611437
• UDI-Public: 14026704611437
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: IPN900275
• Device Catalogue Number: 10140
• Device Lot Number: UNKOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2022
• Supplement Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 03/11/2022
• Supplement Report FDA Received Date: 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown