MAUDE Adverse Event Report: FOREFRONT MEDICAL TECHNOLOGY; AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY

Model Number 33730

Device Problem Air Leak (1008)

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

Event Date 11/10/2017

Event Type  malfunction  

Manufacturer Narrative

Shiley laryngeal mask classification is airway, oropharyngeal, anesthesiology, regulation number (b)(4) and is 510k exempt.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during the procedure, the mask was pierced or deflated and had a leakage.The customer indicated that the patient was intubated and that the patient status was unknown.Additional information provided indicated that there was no medical intervention required or delay in treatment and nothing was used to lubricate the mask before insertion.

• Type of Device: AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY
• Manufacturer (Section D): FOREFRONT MEDICAL TECHNOLOGY; no.8 changyang road wujin econ; changzhou jiangsu,100 213 1 45; CN 213 145
• Manufacturer (Section G): FOREFRONT MEDICAL TECHNOLOGY; no.8 changyang road wujin econ; changzhou jiangsu,100 213 1 45; CN 213 145
• Manufacturer Contact: sharon murphy ; 15 hampshire street; mansfield, MA 02048 ; 2034925267
• MDR Report Key: 7162481
• MDR Text Key: 96357309
• Report Number: 2936999-2018-00005
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/03/2018

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: 09/01/2018
• Device Model Number: 33730
• Device Catalogue Number: 33730
• Device Lot Number: ELE1509007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2017
• Initial Date FDA Received: 01/03/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1