MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; SZ 4, DISP, SOFT, MASK, LARYNGEAL, PVC

Catalog Number	DYND300040S
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that during use of the laryngeal mask airway (lma) for an elective case, the lma's cuff was noted stiff.This reportedly resulted in the lma cuff not seating correctly in the patient's airway and the patient developing laryngospasm.Per report, during insertion, lubricating water-based jelly was used and lma was partially deflated before inserting into patient.As soon as the laryngeal mask was inflated with 5 cc of air, the patient reportedly developed laryngospasm.The laryngeal mask airway was immediately removed, patient was given succinylcholine (drug), and another brand of laryngeal mask airway was inserted.No further tests/treatment was reportedly required for the patient's laryngospasm.Due to the reported laryngospasm and required medical intervention, this medwatch is being filed.No issues with the returned companion sample was identified.A definitive root cause for the reported event could not be identified at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the laryngeal mask airway's (lma) cuff was stiff resulting in the lma not seating correctly in the patient's airway and the patient developing laryngospasm.

• Common Device Name: SZ 4, DISP, SOFT, MASK, LARYNGEAL, PVC
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8663935
• Report Number: 1417592-2019-00081
• Device Sequence Number: 2182309
• Product Code: CAE
• UDI-Device Identifier: 10888277699526
• UDI-Public: 10888277699526
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/03/2019

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 Catalogue Number: DYND300040S
• Device Lot Number: 59219020326
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 06/03/2019
• 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