MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP Medline; LARYNGEAL MASK, SZ 4, FLEXIBLE, DISP

Model Number DYND300040S

Device Problems Device Dislodged or Dislocated (2923); Unintended Movement (3026)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/01/2022

Event Type  Injury  

Event Description

According to the facility when repositioning the patient to a sitting position the laryngeal mask 'pops out, requiring the staff to push the device back in'.

Manufacturer Narrative

According to the facility when repositioning the patient to a sitting position the laryngeal mask 'pops out, requiring the staff to push the device back in'.The sample is not available for evaluation.No additional information is available at this time.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: Medline
• Type of Device: LARYNGEAL MASK, SZ 4, FLEXIBLE, DISP
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 15587997
• MDR Text Key: 301577604
• Report Number: 1417592-2022-00190
• Device Sequence Number: 1
• Product Code: CAE
• UDI-Device Identifier: 10888277699526
• UDI-Public: 10888277699526
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/12/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: DYND300040S
• Device Catalogue Number: DYND300040S
• Device Lot Number: 59222051032
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/29/2022
• Initial Date FDA Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention