MAUDE Adverse Event Report: MIDMARK CORPORATION RITTER 104; RITTER EXAM TABLE

Model Number 104

Device Problem Unintended Movement (3026)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 12/03/2019

Event Type  Injury  

Event Description

Per documentation received by midmark, patient alleges that the examination table tipped as he was alighting the table, causing him to fall to the floor suffering a bimalleolar fracture to the right ankle.At this time, it has not been verified that the reported incident involved a midmark exam table.

Manufacturer Narrative

Midmark received notice from a third party organization on november 11, 2021 regarding an incident reported to have taken place in (b)(6) 2019 in which a patient fell from an examination table resulting in a bimalleolar fracture to the right ankle.Midmark attempted to obtain further information from the third party about the event, but no additional information was provided.The table information that would facilitate further investigation also was not made available to midmark.The examination table said to have been involved in this incident had an end of service date of 2016.

• Brand Name: RITTER 104
• Type of Device: RITTER EXAM TABLE
• Manufacturer (Section D): MIDMARK CORPORATION; 60 vista drive; versailles OH 45380
• Manufacturer (Section G): MIDMARK CORPORATION; 60 vista drive; versailles OH 45380
• Manufacturer Contact: sherrinda baker ; 60 vista drive; versailles, OH 45380 ; 9375267990
• MDR Report Key: 12960882
• MDR Text Key: 281919615
• Report Number: 1523530-2021-00005
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 104
• Device Catalogue Number: 104
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other