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

Model Number IPN900275

Device Problem Dent in Material (2526)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/18/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "slight herniation of the cuff, the physician reported she did not feel it sealed that well".No patient involvement reported.

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 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)
• Type of Device: 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
• MDR Text Key: 292178553
• Report Number: 9681900-2022-00012
• Device Sequence Number: 1
• Product Code: CAE
• UDI-Device Identifier: 14026704611437
• UDI-Public: 14026704611437
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Initial Date Manufacturer Received: 02/18/2022
• Initial Date FDA Received: 03/11/2022
• Supplement Dates Manufacturer Received: 04/04/2022
• Supplement Dates FDA Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1