MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP Medline Industries, Inc.; TOTAL JOINT PACK

Model Number DYNJ59581C

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2022

Event Type  Injury  

Event Description

It was reported that the yankauer broke off in a patient.No additional details are available related to the customer reported issue.

Manufacturer Narrative

It was reported that the yankauer broke off in a patient.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.The sample was not returned for evaluation.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

• Brand Name: Medline Industries, Inc.
• Type of Device: TOTAL JOINT PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 13393029
• MDR Text Key: 288184373
• Report Number: 1423395-2022-00002
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 10193489372120
• UDI-Public: 10193489372120
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/31/2022

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 Model Number: DYNJ59581C
• Device Catalogue Number: DYNJ59581C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/03/2022
• Initial Date FDA Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other