MAUDE Adverse Event Report: FOREFRONT MEDICAL TECHNOLOGY SHILEY; LARYNGEAL MASK, SIZE 2, 10-20 KG

Model Number 33720

Device Problem Difficult To Position (1467)

Patient Problems Hemorrhage/Bleeding (1888); Low Oxygen Saturation (2477)

Event Date 10/14/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Patient information (id, age, sex, weight) as well as additional information associated with the complaint have been requested and is either unknown, will not be made available to medtronic, or will be provided and updated in a supplemental report.The customer did not retain the lot number which determines the date of manufacture.Shiley ¿laryngeal mask classification is airway, oropharyngeal, anesthesiology, regulation number 868.5110 and is 510k exempt.

Event Description

The customer reports that the mask was too soft and difficult to apply.It what also reported there was desaturation of the patient related to the difficulty inserting and moving the secondary mask was reported.In this report it was stated there was endo-buccal bleeding noticed, with a patient post surgery.Additional information has been requested.

• Brand Name: SHILEY
• Type of Device: LARYNGEAL MASK, SIZE 2, 10-20 KG
• Manufacturer (Section D): FOREFRONT MEDICAL TECHNOLOGY; no.8 changyang road; wujin economic zone; changzhou jiangsu 213 1 45; CH 213 145
• Manufacturer (Section G): FOREFRONT MEDICAL TECHNOLOGY; no.8 changyang road; wujin economic zone; changzhou jiangsu 213 1 45; CH 213 145
• Manufacturer Contact: ray maroofian ; 2101 faraday ave; carlsbad, CA 92008 ; 7606035334
• MDR Report Key: 6119473
• MDR Text Key: 60624796
• Report Number: 2936999-2016-00963
• 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: consumer,foreign,health profe
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/25/2016

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: 33720
• Device Catalogue Number: 33720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2016
• Initial Date FDA Received: 11/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention