MAUDE Adverse Event Report: DALIAN GOODWOOD MEDICAL CARE LTD. MEDICHOICE; TONGUE DEPRESSOR, 6", WOOD SHAFT

Model Number WOD3003

Device Problem Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/24/2016

Event Type  malfunction  

Event Description

(b)(4), the initial importer and private-label distributor of medichoice tongue depressor, wod3003, lot: 1512dg09b, received a product problem report from end user, (b)(6), on (b)(6) 2016.The end user reported that a defective tongue depressor was used on a patient.An anesthesiologist used the tongue depressor while intubating a patient.The anesthesiologist did not remember seeing that the tongue depressor was defective until after it was used.Therefore, the health professional was uncertain whether a piece of the depressor was detached during intubation or whether it was previously missing a piece.An emergency laryngoscopy was performed to make sure that there were no pieces of the depressor in the patient's airway.The procedure confirmed that none of the tongue depressor was found to have detached in the patient's airway.

• Brand Name: MEDICHOICE
• Type of Device: TONGUE DEPRESSOR, 6", WOOD SHAFT
• Manufacturer (Section D): DALIAN GOODWOOD MEDICAL CARE LTD.; 3-91 jiulicun yongzheng street; jinzhou district; dalian liaoning 116100 ; CH
• MDR Report Key: 5803002
• MDR Text Key: 50068038
• Report Number: 3003753847-2016-00002
• Device Sequence Number: 1
• Product Code: FMA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/18/2016,05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: WOD3003
• Device Catalogue Number: WOD3003
• Device Lot Number: 1512DG09B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/18/2016
• Distributor Facility Aware Date: 05/25/2016
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other