LATERAL SUPPORT
Received Feb 24, 2021 · Event occurred Feb 17, 2021
Report 3013876692-2021-00016 · MDR key 11372303
Device
Generic name
Table And Attachments, Operating-room
Manufacturer
Holger UllrichModel number
100211C0Catalog number
100211C0
Product problems
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
Patient
Not reported
- Muscle Weakness/Atrophy
- Nerve Damage
- Numbness
- No Information
- Muscle Weakness/Atrophy
- Nerve Damage
- Numbness
- No Information
Narrative
Additional 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 MEDWACHT WILL BE SUBMITTED.
Description of Event or Problem
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).
Description of Event or Problem
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 CONTINUOUS REHABILITATION AT THE HOSPITAL. MANUFACTURER REFERENCE#: (B)(4).
Additional 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.