MAUDE Adverse Event Report: GOODWOOD MEDICAL CARE LTD GOODWOOD MEDICAL CARELTD; NASOPHARYNGEAL SWAB

Catalog Number GW-1237NP

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Event Description

We actually had a swab break off in the nasopharynx that had to be retrieved in the er.Performed by an experienced ma.

• Brand Name: GOODWOOD MEDICAL CARELTD
• Type of Device: NASOPHARYNGEAL SWAB
• Manufacturer (Section D): GOODWOOD MEDICAL CARE LTD; 1-2floor, 3-919 jiulicun; yongzheng street, jinzhou dist; dalian, liaoning 11610 0; CH 116100
• MDR Report Key: 10549167
• MDR Text Key: 207734287
• Report Number: 1924669-2020-00004
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: GW-1237NP
• Device Lot Number: 20200508
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/17/2020
• Distributor Facility Aware Date: 07/31/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other