MAUDE Adverse Event Report: CHANGZHOU NEWRISE MEDICAL & HYGIENE PRODUCTS CO.,L MCKESSON BRANDS; ORAL FOAM SWABSTICK, W/DENTIFRICE MINT

Catalog Number 4834

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/16/2022

Event Type  Injury  

Event Description

It was reported by the customer, that while the oral swab was being used in a patient's mouth, the sponge part of the swab disengaged from the stick part of the swab and became lost somewhere inside the patient.Swab head was eventually removed via an egd procedure.Patient has special medical needs and has a cuffed trach tube and is ventilated.

• Brand Name: MCKESSON BRANDS
• Type of Device: ORAL FOAM SWABSTICK, W/DENTIFRICE MINT
• Manufacturer (Section D): CHANGZHOU NEWRISE MEDICAL & HYGIENE PRODUCTS CO.,L; no.39 chuangye road; zhulin town, jintan district; chanzghou, jiangsu 21324 1; CH 213241
• MDR Report Key: 15752356
• MDR Text Key: 303236421
• Report Number: 1451040-2022-00056
• Device Sequence Number: 1
• Product Code: KXF
• 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: 11/08/2022

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 Catalogue Number: 4834
• Device Lot Number: CCRA12-01
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/08/2022
• Distributor Facility Aware Date: 10/18/2022
• Device Age: 10 MO
• Event Location: Home
• Date Report to Manufacturer: 11/08/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female