|
Model Number N/A |
Device Problems
Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Itching Sensation (1943); Skin Inflammation/ Irritation (4545)
|
Event Type
Injury
|
Manufacturer Narrative
|
Zimmer biomet complaint (b)(4).Date of event: the event occurred sometime in (b)(6) 2022.Medical product: unknown.Therapy date: unknown.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is complete, a supplemental medwatch 3500a will be submitted.
|
|
Event Description
|
It was reported by the patient that she is having a skin irritation from the 72r electrodes on the lumbar area.The skin irritation started a few days after she started using them.The skin is red and itchy.The patient stopped using them in (b)(6).The electrodes were changed and rotated every day.The patient used the cover patches, but she does not know if they caused any itchiness.The area is clean with soap, water, alcohol, and baby wipes.The patient has sensitive skin and takes blood pressure medication.The patient does not have any allergies and has not used any new products.The patient called her doctor, who told her to stop using the electrodes.The patient was sent replacement 72r electrodes.No additional patient consequences have been reported.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.The device was 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.The following sections have been updated: h6: component codes added 451-electrodes.H6: impact code added to 4648 - insufficient information.H6: clinical code added to 4545 - skin inflammation/ irritation.H6: clinical code added to 1943 - itching sensation.H6: device code updated to 2682 - patient-device incompatibility.H6: investigation code added to 3331 - analysis of production records.H6: investigation code added to 4119 ¿ insufficient information available.H6: investigation findings code added to 3221- no findings available.H6: investigation conclusions code added to 4315 - cause not established.The following sections have been corrected: h6: device code updated to 2993: adverse event without identified device or use problem.
|
|
Event Description
|
It was reported by the patient that she is having skin irritation from the 72r electrodes on the lumbar area.The skin irritation started a few days after she started using them.The skin is red and itchy.The patient stopped using them in january or february.The electrodes were changed and rotated every day.The patient used the cover patches, but she does not know if they caused any itchiness.The area is clean with soap, water, alcohol, and baby wipes.The patient has sensitive skin and takes blood pressure medication.The patient does not have any allergies and has not used any new products.The patient called her doctor, who told her to stop using the electrodes.The patient was sent replacement 72r electrodes.No additional patient consequences have been reported.
|
|
Search Alerts/Recalls
|
|
|