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

Catalog Number GW-1237NP

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/01/2020

Event Type  malfunction  

Event Description

Type of injury - covid swab broke off in patient's nasopharyngeal passages.Treatment for patient due to injury? could not visualize or retrieve swab tip.Patient discharged.Did the swab break at the breakpoint or the neck of the swab?: breakpoint.

• Brand Name: GOODWOOD MEDICAL CARE LTD
• 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: 10401419
• MDR Text Key: 202743364
• Report Number: 1924669-2020-00002
• 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: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• 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: 08/13/2020
• Distributor Facility Aware Date: 07/17/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR