MAUDE Adverse Event Report: HOLGER ULLRICH LATERAL SUPPORT; TABLE AND ATTACHMENTS, OPERATING-ROOM

Model Number 100211C0

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Muscle Weakness (1967); Nerve Damage (1979); Numbness (2415); No Information (3190)

Event Date 02/17/2021

Event Type  Injury  

Manufacturer Narrative

At time of this report the investigation is still ongoing.When the investigation is complete the report will be updated and a follow up medwatch will be submitted.

Event Description

The following was reported.The accessory lateral support was used on a patient.Afterwards we were informed that the patient was injured.Further information concerning the incident and the extend of the injury were requested from the clinic, but not yet provided.Manufacturer report# (b)(4).

Manufacturer Narrative

No damage or malfunction of the affected device was recognized.Due to described symptoms, we assume that the lateral support was positioned in a way that has impaired the affected nerves.We have reviewed our complaints database concerning similar issues and not found any similar complaints.Getinge-maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.

Event Description

The following information concerning the patients injury was received.There was a postoperative numbness in the left upper extremity.The numbness was felt from the left elbow to the fingertips.The grasping power of the fingers of the left hand was reduced.There was a nerve paralysis at the left median nerve and the left anterior interosseous nerve.The patient underwent continous rehabilitation at the hospital.Manufacturer reference # (b)(4).

• Brand Name: LATERAL SUPPORT
• Type of Device: TABLE AND ATTACHMENTS, OPERATING-ROOM
• Manufacturer (Section D): HOLGER ULLRICH; maquet gmbh; kehler strasse 31,; rastatt 76437 ; GM 76437
• MDR Report Key: 11371162
• MDR Text Key: 233246308
• Report Number: 8010652-2021-00003
• Device Sequence Number: 1
• Product Code: BWN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 100211C0
• Device Catalogue Number: 100211C0
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other