MAUDE Adverse Event Report: BIOMEDICAL LIFE SYSTEMS INC. BIOSTIM SD; BIOSTIM SD TENS UNIT

Model Number	KBSD
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	11/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qa investigation included reviewing dhr's for both electrodes and biostim sd.We requested device records from the electrode manufacturer and the device subcontractor.When device master records were reviewed, electrodes #eerc200m lot #b170617 from gmdasz manufacturing company and serial # (b)(4) job # (b)(4) from fuji dynamics both passed in process inspections, final inspections and showed no sign of malfunction.There were no records of deviations from the kitting process.Bmls has sold over (b)(4) units of tens units and has not experienced complaints of burns.Even so, there are contraindications for use in the product manuals.The device was returned from (b)(6) at (b)(6) and inspected upon its arrival.Furthermore, it was thoroughly tested by the engineering dept.The complaint/burns could not be recreated and the device was performing to specifications.Physical therapist (b)(6) reviewed photo sent in by (b)(6) at (b)(6) medical from the end user, (b)(6), and in his professional opinion it seems that the user placed the electrodes on an existing "incision or broken/skin." capa (b)(4) was initiated and completed to document the investigation.Capa was initiated to monitor and review warnings and use of biostim sd and contraindications portion of the manual, report sent to health (b)(4).The device was returned to the customer (end user).Capa (b)(4) was initiated to address the fact that the medwatch form 3500a was sent to bmls test account in error.
Event or Problem Description
Our customer, (b)(6) from (b)(6) medical emailed in january 2019 us that one of her customers, (b)(6), had used biostim sd tens unit and placed the electrodes on her buttocks.The exact date was not supplied.She said it was probably (b)(6) 2018.Patient complained that she encountered burns within 5 minutes of using the device.The user told (b)(6) about it who contacted biomedical life systems (bmls) and sent in the photo.We asked (b)(6) to obtain information from (b)(6) with details of the incident.She declined.Bmls contacted (b)(6) to obtain details of the event.

• Brand Name: BIOSTIM SD
• Common Device Name: BIOSTIM SD TENS UNIT
• Manufacturer (Section D): BIOMEDICAL LIFE SYSTEMS INC.; 1954 kellogg ave; carlsbad, ca
• MDR Report Key: 9836506
• Report Number: 2024292-2019-00001
• Device Sequence Number: 19604767
• Product Code: GZJ
• UDI-Device Identifier: 00857771003088
• UDI-Public: 00857771003088
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K033455
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Inspection,Other
• Type of Report: Initial
• Report Date (Section B): 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: KBSD
• Device Catalogue Number: KBSD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 2 YR
• Event Location: Home
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 03/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR