SKINTACT
Report
- Report Number
- 8020045-2025-00016
- Event Type
- Injury
- Date Received
- July 15, 2025
- Report Date
- September 25, 2025
- Manufacturer
- LEONHARD LANG GMBH
- Product Code
- DRX
- PMA / PMN Number
- K023503
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- 501
Narratives
RETAINED SAMPLES OF THE CONCERNED LOT NUMBER HAVE BEEN INSPECTED VISUALLY AND TESTED MECHANICALLY. MECHANICAL TESTS FOR ADHESION WERE PERFORMED ON 3 RETAINED SAMPLES OF THE CLAIMED LOT NUMBER. ALL TESTED SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. ADDITIONALLY A SKIN ADHESION TEST ON A TEST PERSON WAS PERFORMED FOR ABOUT 1 HOUR STICKING THE ECG TEST ELECTRODES TO THE SKIN. NO FAULTS COULD BE DETECTED. WE HAVE REQUESTED A FILLED IN QUESTIONNAIRE AND CUSTOMER SAMPLES FOR FURTHER INVESTIGATION. WE WILL PROVIDE FURTHER INFORMATION, INVESTIGATION RESULTS AND ANY CONCLUSION IN A FOLLOW UP REPORT.
RETAINED SAMPLES OF THE CONCERNED LOT NUMBER HAVE BEEN INSPECTED VISUALLY AND TESTED MECHANICALLY. MECHANICAL TESTS FOR ADHESION WERE PERFORMED ON 3 RETAINED SAMPLES OF THE CLAIMED LOT NUMBER. ALL TESTED SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. ADDITIONALLY A SKIN ADHESION TEST ON A TEST PERSON WAS PERFORMED FOR ABOUT 1 HOUR STICKING THE ECG TEST ELECTRODES TO THE SKIN. NO FAULTS COULD BE DETECTED. THE INVOLVED DEVICES HAVE NOT BEEN MADE AVAILABLE TO US. WE HAVE RECEIVED SAMPLES IN TWO ALREADY OPENED POUCHES OF THE CLAIMED LOT NUMBER 250310-0358. ADDITIONALLY WE HAVE RECEIVED FROM LOT NUMBER 250304-0354 TWO FULLY FILLED BOXES ORIGINAL CLOSED WITH 1000 ELECTRODES AND ONE ALREADY OPENED POUCH OF THE SAME LOT NUMBER SHOWING A HANDWRITTEN REMARK: "BAD". WE HAVE ALSO RECEIVED ONE ALREADY OPENED POUCH FROM LOT NUMBER 250129-0358 AND TWO ALREADY OPENED POUCHES FROM LOT NUMBER 250310-0358. ALL RETURNED CUSTOMER SAMPLES WERE INSPECTED VISUALLY. MECHANICAL TESTS WERE PERFORMED ON 3 SAMPLES EACH RETURNED CUSTOMER POUCH. ALL TESTED SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS COULD BE DETECTED. COMPARING THE ADHESIVE FORCE OF THE CLAIMED ELECTRODE LOT NUMBER WITH THE RETAINED SAMPLES AND THE ELECTRODE LOT NUMBERS THE CUSTOMER HAS ALSO RETURNED HAS SHOWN THAT THERE ARE NO DIFFERENCES NOTICEABLE IN THE ADHESION FORCE. THE ADHESION FORCE TESTING HAS SHOWN THAT THE ADHESION FORCE VALUES HAVE NOT CHANGED AND DO NOT FLUCTUATE. ADDITIONALLY WE HAVE CONDUCTED SKIN WEARING TESTS. ELECTRODES FROM EACH RETURNED CUSTOMER POUCH HAVE BEEN APPLIED TO A TEST PERSON WITHOUT PRIOR SKIN PREPARATION. THE DURATION OF WEARING WAS ABOUT 2 HOURS. NO FAILURES OR DEVIATIONS HAVE BEEN DETECTED WHEN RELEASING THE ELECTRODES FROM THE SKIN. DESPITE REPEATED REQUESTS WE HAVE NOT RECEIVED FURTHER INFORMATION ON THE PATIENT, THE SKIN PREPARATION, A POSSIBLE MEDICATION THAT HAS A SKIN WEAKENING EFFECT OR INFORMATION ON THE TIME OF WEARING HAS BEEN PROVIDED. A SKIN INCIDENT OF THE NATURE DESCRIBED CAN BE CAUSED BY THE ADHESIVE AND BY THE STATE OF THE SKIN ITSELF. CERTAIN MEDICAL CONDITIONS (LIKE DIABETES) AND CERTAIN MEDICATION (LIKE STEROIDS) CAN WEAKEN THE SKIN. INFORMATION TO THIS EXTENT ALONG WOULD BE CRUCIAL TO INVESTIGATE, WHETHER THIS HAS PLAYED ANY ROLE. UNFORTUNATELY IT WAS NOT PROVIDED. THE IFU STATES "AFTER USE, CAREFULLY REMOVE THE ELECTRODE USING ONE HAND WHILST SUPPORTING THE SKIN BENEATH IT WITH THE OTHER. RIPPING OFF THE ELECTRODE OR PEELING IT OFF QUICKLY MAY DAMAGE THE SKIN. EXERCISE PARTICULAR CAUTION IF THE SKIN IS EXCEPTIONALLY SENSITIVE, ESPECIALLY WITH CHILDREN BUT ALSO WITH ELDERLY PATIENTS, DIABETICS, OR PATIENTS ON A PROLONGED COURSE OF CERTAIN MEDICATIONS KNOWN TO CAUSE DERMATOLOGICAL SIDE EFFECTS". HOWEVER, ON THE PROVIDED PATIENT PICTURES THE PARCHMENT SKIN OF AN ELDERLY PATIENT IS SHOWN AND AN ELECTRODE IS BEING PULLED OFF. THE PICTURE DOES NOT SHOW THE OTHER HAND OF THE OPERATOR SUPPORTING THE SKIN AS INSTRUCTED. THIS WOULD CONSTITUTE A DEVIATION FROM THE IFU. WE ASSUME THE PATIENT CONDITION HAS MOST LIKELY CONTRIBUTED TO THE CLAIMED INCIDENT. NO FURTHER CONCLUSION CAN BE DRAWN. AS NO FURTHER INFORMATION WAS MADE AVAILABLE DESPITE REPEATED REQUESTS, WE CONSIDER THE INVESTIGATION CLOSED.
ON (B)(6) 2025, WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING A SKINTACT ELECTRODE REF.: FSWB00 AT (B)(6) HOSPITAL IN THE (B)(6). THE INITIAL REPORTER INFORMED (B)(6) ABOUT: "THE TABS ARE STICKING TO THE PATIENTS SKIN AND CAUSING THE SKIN TO BREAK ON CAREFUL REMOVAL. AT TIMES WE HAVE TO BATHE THE TAB WITH WATER TO SOFTEN THE ADHESIVE AND PREVENTING ANY FURTHER INJURIES TO OUR PATIENTS. WE KEEP THE TABS IN A SEALED PACKET AND COOL CUPBOARD." WE HAVE REQUESTED CUSTOMER SAMPLES AND A FILLED IN QUESTIONNAIRE. WE WILL PROVIDE A FOLLOW UP REPORT ONCE WE HAVE RECEIVED ANY.
ON (B)(6), 2025, WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING A SKINTACT ELECTRODE REF.: FSWB00 AT (B)(6) HOSPITAL IN THE UK. THE INITIAL REPORTER INFORMED LEONHARD LANG ABOUT: "THE TABS ARE STICKING TO THE PATIENTS SKIN AND CAUSING THE SKIN TO BREAK ON CAREFUL REMOVAL. AT TIMES WE HAVE TO BATHE THE TAB WITH WATER TO SOFTEN THE ADHESIVE AND PREVENTING ANY FURTHER INJURIES TO OUR PATIENTS. WE KEEP THE TABS IN A SEALED PACKET AND COOL CUPBOARD." LATER ON WE HAVE RECEIVED A FANNIN FORM SPECIFYING THAT THE ECG POUCH WAS "OPENED ON DAY OF USE" AND THE FAILURE WAS "DETECTED PRIOR TO USE". "THE ADHESIVE ON THE ECG ELECTRODES IS TOO STRONG AND HAS BROKEN THE PATIENTS SKIN ON REMOVAL. EXTREMELY DIFFICULT TO PULL OFF SKIN AT TIMES AND CAN CAUSE BLOOD BLISTERS. IN SOME CASES WE WERE UNABLE TO REMOVE THEM AND SOAKED THE AREA IN WATER TO MAKE THE ADHESIVE SOFTER." IT WAS ALSO STATED WITHIN THE FORM THAT "WHEN THE SKIN WAS BROKEN A DRESSING WAS PUT ON THE AREA. OTHER PATIENTS LEFT WITH BRUISING ON THE AREA." FURTHER ON IT WAS SPECIFIED ON THE QUESTION "MEDICAL/SURGICAL INTERVENTION REQUIRED? (OTHER THAN ROUTINE CHANGE OR MAINTENANCE): NO". WE ALSO HAVE RECEIVED TWO PICTURES. ONE PICTURE SHOWS AN ECG ELECTRODE APPLIED TO A PATIENT'S RIGHT FOREARM WHICH IS BEING PULLED OFF BY A USER. THE SECOND PICTURE SHOWS THE ADHESIVE OF THE ECG ELECTRODE FOAM STICKING TO THE PATIENT SKIN AND FORMING STICKY THREAD-LIKE RESIDUES THAT FORM BETWEEN THE ECG ELECTRODE AND THE SKIN WHEN REMOVED. LATER ON WE HAVE RECEIVED ADDITIONAL 3 PICTURES SHOWING AN ELDERLY PATIENT SKIN ASSUMING TO BE A PARCHMENT SKIN. THE PICTURES ARE SHOWING HOW AN ECG ELECTRODE IS BEING REMOVED FROM THE PATIENT SKIN AND THE SKIN IS PULLED ALONG WITH IT WITHOUT ANY SUPPORT. IN ANY CASE, THE SKIN LOOKS THIN AND THE TISSUE VERY FRAGILE. NO DETAILS ON THE PATIENT, THE SKIN PREPARATION, A POSSIBLE MEDICATION THAT HAS A SKIN WEAKENING EFFECT OR OTHER INFORMATION ON THE TIME OF WEARING HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1573205 | SKINTACT | ECG ELECTRODE | DRX | LEONHARD LANG GMBH | FSWB00 | 250310-0358 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |