MAUDE Adverse Event Report: EBI, LLC. SOFT-TOUCH ELECTRODES, 63B

Model Number N/A

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Irritation (1941); Itching Sensation (1943); Swelling (2091)

Event Date 01/29/2019

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).The device will not be returned for analysis since it has been discarded by the patient.However, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that the patient got a rash from the 63b electrodes.The patient indicated in a follow up call that he started using the 63b electrodes in (b)(6) but did not get the reaction until mid-(b)(6).At that time, he stopped using the 63b electrodes.His skin was red, itchy, sensitive and had bumps.The rash began under the electrodes but it spread within a week onto the entire lower back and upper chest area.The patient visited his doctor in (b)(6) 2019, two weeks after the irritation started and received a prescription for prednisone tablet and a topical cream (patient could not remember the name of the cream).

Event Description

It was reported that the patient got a rash from the 63b electrodes.The patient indicated in a follow up call that he started using the 63b electrodes in september but did not get the reaction until mid-december.At that time, he stopped using the 63b electrodes.His skin was red, itchy, sensitive and had bumps.The rash began under the electrodes but it spread within a week onto the entire lower back and upper chest area.The patient visited his doctor in (b)(6) 2019, two weeks after the irritation started and received a prescription for prednisone tablet and a topical cream (patient could not remember the name of the cream).No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The product was not returned to zimmer biomet because it was discarded by the patient.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any future information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.The following sections were updated: b5: final statement added.D4: unique identifier (udi) number added.D11: medical product: biomet spinalpak assembly catalog #: 1067716 serial #: (b)(6).D11: therapy date: unknown.E3: occupation: non-healthcare professional.G3: consumer added.G4: date received by manufacturer added.G7: type of report added.H2: follow-up type.H3: device evaluated by manufacturer updated to no.H6: method code updated to 4114 - device not returned.H6: results code updated to 3221 - no findings available.H6: conclusions code updated to 4315- cause not established.H10: additional narratives/data.

Event Description

It was reported that the patient got a rash from the 63b electrodes.The patient indicated in a follow up call that he started using the 63b electrodes in september but did not get the reaction until mid-december.At that time, he stopped using the 63b electrodes.His skin was red, itchy, sensitive and had bumps.The rash began under the electrodes but it spread within a week onto the entire lower back and upper chest area.The patient visited his doctor in (b)(6) 2019, two weeks after the irritation started and received a prescription for prednisone tablet and a topical cream (patient could not remember the name of the cream).No additional patient consequences were reported.

Manufacturer Narrative

This follow up report is being submitted to relay corrected information.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.The following sections were corrected: d11: medical product: biomet spinalpak assembly serial #: updated to (b)(6).

• Brand Name: SOFT-TOUCH ELECTRODES, 63B
• Type of Device: ELECTRODES
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• MDR Report Key: 8344350
• MDR Text Key: 136297568
• Report Number: 0002242816-2019-00004
• Device Sequence Number: 1
• Product Code: LOF
• Combination Product (y/n): N
• PMA/PMN Number: P850022/S017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 106130-22
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR