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

Model Number 33730

Device Problem Human-Device Interface Problem (2949)

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

Event Date 01/31/2017

Event Type  Injury  

Manufacturer Narrative

Shiley ¿laryngeal mask classification is airway, oropharyngeal, anesthesiology, regulation number (b)(4) and is 510k exempt.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report the mask was difficult to apply.Customer indicated there was no injury to patient.Medtronic is requesting additional information regarding the patient outcome as well as the circumstances of this event.

• Brand Name: SHILEY
• 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: 6539149
• MDR Text Key: 74252323
• Report Number: 2936999-2017-05176
• 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: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/10/2017

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
• Device Operator: Health Professional
• Device Model Number: 33730
• Device Catalogue Number: 33730
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/10/2017
• Initial Date FDA Received: 05/02/2017
• 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
• Patient Outcome(s): Required Intervention