SKINTACT
Report
- Report Number
- 8020045-2022-00003
- Event Type
- Injury
- Date Received
- January 25, 2022
- Date of Event
- October 27, 2021
- Report Date
- April 20, 2022
- Manufacturer
- LEONHARD LANG GMBH
- Product Code
- GEI
- UDI-DI
- 19005531502998
- PMA / PMN Number
- K063161
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- 003
Narratives
RETAINED SAMPLES OF THE SAME LOT HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY. MECHANICAL TESTS WERE PERFORMED ON 3 RETAINED SAMPLES. ALL TESTED SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS WERE DETECTED. THE INVOLVED DEVICES HAVE NOT BEEN MADE AVAILABLE TO US. THE IFU FOR SKINTACT DIPERSIVE NEUTRAL ELECTRODES STATES AS INTENDED USE: "NEUTRAL ELECTRODES ARE INTENDED AS ACCESSORIES FOR ELECTROSURGICAL DEVICES. NEUTRAL ELECTRODES ARE NON-STERILE; THEY ARE INTENDED ONLY FOR SINGLE USE ON INTACT (UNINJURED) SKIN AND LEAD ENERGY FROM THE PATIENT TO THE ELECTROSURGICAL DEVICE." IT APPEARS THE DEVICE HAS BEEN USED IN AN APPLICATION NOT COMPRISED IN THE INTENDED USE. WE HAVE SENT A FIRST COMMUNICATION TO WINBACK TO IMMEDIATELY STOP RECOMMENDING OR APPEARING TO RECOMMEND THE USE OF SKINTACT DIPERSIVE NEUTRAL ELECTRODES WITH WINBACK ELECTROTHERAPY DEVICES. WE HAVE REQUESTED THAT WINBACK MAKE SURE THAT USERS OF WINBACK ELECTROTHERAPY DEVICES ARE MADE AWARE OF THIS. IN ADDITION, WE HAVE ASKED FOR FURTHER INFORMATION ABOUT THE APPLICATION OUR DEVICE HAD BEEN USED AS AN ACCESSORY FOR. WE HAVE CONTACTED BY WINBACK AND HAVE BEEN INFORMED THEY ARE "PROCESSING YOUR [(B)(6)] REQUESTS AND WILL GET BACK TO YOU [(B)(6)] BY THE REQUIRED DATE, (B)(6) 2022." WE WILL PROVIDE A FOLLOW UP REPORT ONCE WE HAVE RECEIVED FURTHER INFORMATION.
RETAINED SAMPLES OF THE SAME LOT HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY. MECHANICAL TESTS WERE PERFORMED ON 3 RETAINED SAMPLES. ALL TESTED SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS WERE DETECTED. THE INVOLVED DEVICES HAVE NOT BEEN MADE AVAILABLE TO US. WE HAVE SENT A COMMUNICATION TO WINBACK TO IMMEDIATELY STOP RECOMMENDING OR APPEARING TO RECOMMEND THE USE OF SKINTACT DISPERSIVE NEUTRAL ELECTRODES WITH WINBACK ELECTROTHERAPY DEVICES. WE HAVE REQUESTED THAT WINBACK MAKE SURE THAT USERS OF WINBACK ELECTROTHERAPY DEVICES ARE MADE AWARE OF THIS. THE IFU FOR SKINTACT DISPERSIVE NEUTRAL ELECTRODES STATES AS INTENDED USE: "NEUTRAL ELECTRODES ARE INTENDED AS ACCESSORIES FOR ELECTROSURGICAL DEVICES. NEUTRAL ELECTRODES ARE NON-STERILE; THEY ARE INTENDED ONLY FOR SINGLE USE ON INTACT (UNINJURED) SKIN AND LEAD ENERGY FROM THE PATIENT TO THE ELECTROSURGICAL DEVICE." IT APPEARS THE DEVICE HAS BEEN USED IN AN APPLICATION NOT COMPRISED IN THE INTENDED USE. WE HAVE MADE COMPANY WINBACK AWARE [TRANSLATED FROM GERMAN TO ENGLISH LANGUAGE]: UNTIL THE SKINTACT DISPERSIVE NEUTRAL ELECTRODES RS25 HAVE BEEN QUALIFIED AND APPROVED FOR USE WITH ELECTROTHERAPY DEVICES FOR THERAPEUTIC PURPOSES, WINBACK BEARS SOLE RESPONSIBILITY FOR ANY USE OF THE PRODUCTS THAT DEVIATES FROM THE INTENDED USE OF THE ELECTRODES DEFINED BY (B)(6). THIS ALSO INCLUDES LIABILITY FOR DAMAGE SUFFERED BY PATIENTS WHEN USING THE DISPERSIVE NEUTRAL ELECTRODES IN COMBINATION WITH THE ELECTROTHERAPY DEVICES FOR THERAPEUTIC PURPOSES. WE EXPRESSLY ASSUME NO LIABILITY FOR THE (LACK OF) COMPATIBILITY OF THE SKINTACT NEUTRAL ELECTRODES RS25 WITH ELECTROTHERAPY DEVICES FOR THERAPEUTIC PURPOSES. WE HAVE REQUESTED FURTHER INFORMATION ON THE PATIENT INCIDENT AND HAVE RECEIVED THE INFORMATION [TRANSLATED FROM GERMAN TO ENGLISH LANGUAGE] THAT: "WE'VE BEEN USING YOUR [LEONHARD LANG] PRODUCT FOR ABOUT 6 YEARS (...) OUR [WINBACK] ELECTROTHERAPY DEVICES ARE MARKETED BY US WORLDWIDE. OVER THE PAST FEW YEARS, WE HAVE NOT RECORDED ANY INCIDENT SIMILAR TO THE PRESENT CASE. THE INCIDENT OCCURRED DUE TO AN UNFORTUNATE INTERACTION OF AN ELECTRODE USED WITHOUT 100% SKIN CONTACT AND A WEAK PERCEPTION OF HEAT BY THE PATIENT. WE HAVE SPOKEN TO THE (B)(6) CLINIC WHO HAVE ASSURED US THAT THERE HAVE BEEN NO OTHER INCIDENTS. YOUR REQUEST IS BASED ON THE CESSATION OF USE OF THE RS25 NEUTRAL ELECTRODES ON THE US MARKET. WE WILL CONDUCT FURTHER TESTING AND, AS A CORRECTIVE ACTION, WILL UPDATE THE IFU THAT A 100% SKIN CONTACT IS ESSENTIAL WHEN USING THESE ELECTRODES" WE ARE CURRENTLY EXAMINING WHETHER THERE IS A POSSIBILITY APPROVING OUR DISPERSIVE NEUTRAL ELECTRODES ACCORDING TO RELEVANT CLAUSES OF STIMULATION APPLICATION REQUIREMENTS FOR THE REQUIRED THERAPEUTIC PURPOSE USAGE OF COMPANY WINBACK. A DEVELOPMENT PROJECT WAS CREATED FOR A POSSIBLE APPROVING. NO FURTHER CONCLUSION CAN BE DRAWN. WE THEREFORE CONSIDER THE INVESTIGATION CLOSED.
ON (B)(6) 2021 WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING TWO DISPERSIVE ELECTRODES. AN ELECTROTHERAPY WAS PERFORMED AT (B)(6) MEDICAL INSTITUTE. TWO MONITORING DISPERSIVE ELECTRODES (MODEL SKINTACT RS25) AND A WINBACK ELECTROTHERAPY DEVICE WERE USED. FDA MEDWATCH REPORT MW5105414 STATES A PATIENT RECEIVED ELECTROTHERAPY WITH A WINBACK DEVICE (510 (K): K162828) AT JOHNS HOPKINS MEDICAL INSTITUTE IN BALTIMORE. THE DEVICE WAS USED WITH TWO SKINTACT NEUTRAL ELECTRODES RS25 AS ACCESSORIES. A DAY AFTER THE THERAPY TWO BURNS WERE DISCOVERED ON THE PATIENT'S BACK, SUPPOSEDLY WHERE ONE OF THE TWO NEUTRAL ELECTRODES HAD BEEN PLACED DURING THERAPY. IN THE REPORT IT WAS STATED THAT THE PATIENT INJURY WAS TREATED WITH "ANTIBIOTICS AND GIVEN TOPICAL TREATMENT WITH FOLLOW-UP RECOMMENDED AT A BURN CLINIC". FURTHER INFORMATION ON HOW THE PATIENTS SKIN WAS PREPPED AND THE ORIENTATION OF THE ELECTRODES ON THE PATIENT HAVE NOT BEEN DISCLOSED. WE HAVE CONTACTED COMPANY WINBACK FOR CLARIFICATION AND CURRENTLY NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE TO US.
ON (B)(6), 2021 WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING TWO DISPERSIVE ELECTRODES. AN ELECTROTHERAPY WAS PERFORMED AT JOHN HOPKINS MEDICAL INSTITUTE. TWO MONITORING DISPERSIVE ELECTRODES (MODEL SKINTACT RS25) AND A WINBACK ELECTROTHERAPY DEVICE WERE USED. FDA MEDWATCH REPORT MW5105414 STATES A PATIENT RECEIVED ELECTROTHERAPY WITH A WINBACK DEVICE (510 (K): K162828) AT (B)(6) MEDICAL INSTITUTE IN (B)(6). THE DEVICE WAS USED WITH TWO SKINTACT NEUTRAL ELECTRODES RS25 AS ACCESSORIES. A DAY AFTER THE THERAPY TWO BURNS WERE DISCOVERED ON THE PATIENT'S BACK, SUPPOSEDLY WHERE ONE OF THE TWO NEUTRAL ELECTRODES HAD BEEN PLACED DURING THERAPY. IN THE REPORT IT WAS STATED THAT THE PATIENT INJURY WAS TREATED WITH "ANTIBIOTICS AND GIVEN TOPICAL TREATMENT WITH FOLLOW-UP RECOMMENDED AT A BURN CLINIC". FURTHER INFORMATION ON HOW THE PATIENTS SKIN WAS PREPPED AND THE ORIENTATION OF THE ELECTRODES ON THE PATIENT HAVE NOT BEEN DISCLOSED. WE HAVE CONTACTED COMPANY WINBACK FOR CLARIFICATION AND NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE TO US.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 687092 | SKINTACT | ELECTROSURGICAL DISPERSIVE ELECTRODE | GEI | LEONHARD LANG GMBH | RS25 | 200224-0809 | 19005531502998 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |