MAUDE Adverse Event Report: KOO MEDICAL EQUIPMENT (SHANGHAI) CO. LTD CRYSTAL AIRWAY MASK; DISPOSABLE LARYNGEAL MASK

Model Number KM-817

Device Problem Device Expiration Issue (1216)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Product is being imported and distributed that is past expiry date on product label.Expiry date is not listed on product shipper.(b)(6).Distributor contacted and no recall notice to date.

• Brand Name: CRYSTAL AIRWAY MASK
• Type of Device: DISPOSABLE LARYNGEAL MASK
• Manufacturer (Section D): KOO MEDICAL EQUIPMENT (SHANGHAI) CO. LTD; 1 songjiang industrial park; songjiang, shanghai 2016 13; CH 201613
• MDR Report Key: 4551593
• MDR Text Key: 18929636
• Report Number: MW5040938
• Device Sequence Number: 1
• Product Code: CAE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/20/2015

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: Other
• Device Expiration Date: 06/30/2014
• Device Model Number: KM-817
• Device Catalogue Number: LCAM-817
• Device Lot Number: 0906181B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/20/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1