MAUDE Adverse Event Report: MIZUHO (THAILAND) CO., LTD. HANA ORTHOPEDIC TABLE; TABLE, OPERATING-ROOM, ELECTRICAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Swelling (2091)

Event Date 06/10/2019

Event Type  Injury  

Event Description

The pt had total right hip replacement on (b)(6) 2019.A f/u call was made on (b)(6) 2019.The pt reported that her labia was swollen and sore.She reported it to the surgeon, and was referred to an ob/gyn.The pt contacted us on (b)(6) 2019 and stated that she had been two ob/gyns, and will possibly be referred to a plastic surgeon or wound care specialist.Ref # mw5088205.

• Brand Name: HANA ORTHOPEDIC TABLE
• Type of Device: TABLE, OPERATING-ROOM, ELECTRICAL
• Manufacturer (Section D): MIZUHO (THAILAND) CO., LTD.
• MDR Report Key: 8802929
• MDR Text Key: 151575355
• Report Number: MW5088206
• Device Sequence Number: 1
• Product Code: GDC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 59 YR
• Patient Weight: 67