MAUDE Adverse Event Report: TIANJIN MEDIS MEDICAL DEVICE CO. ULTRA CLEAR LARYNGEAL MASK; LARYNGEAL MASK AIRWAY

Model Number 1036050

Device Problem Misassembled (1398)

Patient Problem No Information (3190)

Event Date 12/23/2013

Event Type  Injury  

Event Description

Laryngeal mask cuff separated from laryngeal mask tube while being removed from patient.

• Brand Name: ULTRA CLEAR LARYNGEAL MASK
• Type of Device: LARYNGEAL MASK AIRWAY
• Manufacturer (Section D): TIANJIN MEDIS MEDICAL DEVICE CO.; tianjin ; CH
• Manufacturer (Section G): ANESTHESIA EQUIPMENT SUPPLY, INC.; 24301 roberts dr.; black diamond WA 98010
• Manufacturer Contact: 24301 roberts dr.; black diamond, WA 98010
• MDR Report Key: 3670417
• MDR Text Key: 19804224
• Report Number: 3022477-2014-00001
• Device Sequence Number: 1
• Product Code: CAE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2014

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 Operator: Health Professional
• Device Expiration Date: 05/19/2016
• Device Model Number: 1036050
• Device Catalogue Number: 1036050
• Device Lot Number: 0520000002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2014
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/07/2014
• Device Age: 8 MO
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 02/27/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention