EBI, LLC. SPINALPAK ASSEMBLY; STIMULATOR, SPINAL PAK, NON-INVASIVE (SOFT TOUCH ELECTRODES, 72R)
|
Back to Search Results |
|
Model Number N/A |
Device Problems
Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Burn(s) (1757); Skin Inflammation/ Irritation (4545)
|
Event Type
Injury
|
Manufacturer Narrative
|
The device was not returned to zimvie for investigation.The reported event was not verifiable after the investigation associated with skin irritation.The device history record was reviewed, and no discrepancies related to the reported event were found.No physical and/or functional condition could be found after the dhr that could be considered a causal factor for the reported complaint.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly zimvie will continue to monitor for trends.Zimvie complaint (b)(4).B4: date of event: the event occurred sometime in (b)(6) 2023.D10: medical product: unknown.D10: therapy date: unknown.
|
|
Event Description
|
It was reported that the 72r electrodes irritated the patient's skin.The patient stated that the irritation started at the rehab center, but it was diagnosed by the visiting nurse who stated that she had a second-degree burn.The doctor prescribed an ointment for burns.The nurse dressed the burns with gauze.The patient is not a good historian and does not know or remember what was done.The patient has not used the electrodes and cover patches since the irritation started.The patient is wearing a neck brace.The skin is just pink now.No further circumstances have been reported.
|
|
Search Alerts/Recalls
|
|
|