DECOMPRESSION TABLE
Received Oct 2, 2023 · Event occurred Jul 12, 2019
Report 3007278668-2022-00001 · MDR key 17851353
Device
Product problems
- Use of Incorrect Control/Treatment Settings
- Use of Incorrect Control/Treatment Settings
Patient
Unknown
- Pain
- Pain
Narrative
Description of Event or Problem
IT WAS REPORTED TO THE MANUFACTURER THAT OUR DEVICE WAS PART OF A TREATMENT PROTOCOL FOR A PATIENT BEING TREATED FOR BACK PAIN, SHOULDER PAIN, NECK TIGHTNESS, AND LOWER AND BILATERAL BACK PAIN. AFTER A TREATMENT IN (B)(6) 2019, PERFORMED BY THE ASSISTANT, TREATMENT THAT INVOLVED HEAT FOLLOWED BY DECOMPRESSION, THE PATIENT REPORTED A POP AND EXTREME PAIN IN THE LOWER BACK. THE DOCTOR ASSESSED THE PATIENT AND REPORTEDLY IDENTIFIED THAT THE ASSISTANT HAD INCORRECTLY APPLIED HEAT AND TRACTION. THERE WAS NO REPORT OF ANY MALFUNCTION OF THE DEVICE.
Additional Manufacturer Narrative
A HERNIATED DISC IS CAUSED BY COMPRESSION OF THE DISC WHERE THE DECOMPRESSION DOES THE OPPOSITE, APPLIES DISTRACTION. THE REPORTED INJURY IS IMPOSSIBLE TO BE CAUSED BY THE DECOMPRESSION DEVICE, AND THE REPORTING PARTY DID NOT SUGGEST THE DEVICE WAS THE CAUSE. INCORRECT TREATMENT PROTOCOL BY HEALTH PROFESSIONAL WAS THE CAUSE IDENTIFIED, BUT THE DECOMPRESSION TABLE HAD BEEN PART OF THAT PROTOCOL SO AN INCIDENT REPORT WAS SUBMITTED.