XLBLEU
Report
- Report Number
- 8020045-2025-00012
- Event Type
- Injury
- Date Received
- June 30, 2025
- Date of Event
- April 22, 2025
- Report Date
- August 6, 2025
- Manufacturer
- LEONHARD LANG GMBH
- Product Code
- DRX
- UDI-DI
- 19005531001453
- PMA / PMN Number
- K024247
- 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. 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. NO FAULTS COULD BE DETECTED. ON (B)(6) 2025 WE HAVE RECEIVED 3 ORIGINAL CLOSED CUSTOMER SAMPLE POUCHES FORM THE CONCERNED LOT NUMBER. THE CUSTOMER SAMPLES HAVE BEEN INSPECTED VISUALLY, TESTED MECHANICALLY AND ELECTRICALLY. MECHANICAL TESTS FOR ADHESION WERE PERFORMED ON 3 CUSTOMER SAMPLES EACH RETURNED POUCH IN TOTAL 9 ELECTRODES. ALL TESTED SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. ELECTRICALLY TESTS WERE PERFORMED ON 4 CUSTOMER SAMPLE PAIRS EACH RETURNED POUCH IN TOTAL 24 ELECTRODES. ALL TESTED SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS COULD BE DETECTED. WE HAVE REPEATEDLY REQUESTED FOR A FILLED IN QUESTIONNAIRE AND PICTURES FOR FURTHER INVESTIGATION. ON (B)(6) 2025 WE HAVE BEEN INFORMED THAT "I DON'T BELIEVE THAT CAN PROVIDE MUCH MORE INFORMATION OTHER THAN WHAT'S ALREADY BEEN REPORTED, BUT I HAVE ASKED FOR THEM TO FORWARD ON THE PHOTOS THAT THEY MENTIONED ON THE FORM." LATER ON (B)(6) 2025 WE HAVE BEEN INFORMED THAT "CUSTOMER HAS JUST CONFIRMED THAT THEY ACTUALLY DON'T HAVE ANY PHOTOS SO PLEASE GO AHEAD WITH THE INFORMATION YOU ALREADY HAVE (...)." AS NO FURTHER INFORMATION WAS AVAILABLE DESPITE REPEATED REQUESTS NO CONCLUSION CAN BE DRAWN WHAT MIGHT HAVE CAUSED THE CLAIMED FAILURE. WE THEREFORE CONSIDER THE INVESTIGATION AND THE REPORT CLOSED.
ON (B)(6) 2025, WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING A XLBLEU ECG ELECTRODE REF.: FS-WA01C+/10 (OUR MODEL.: FSVM01/10) AT AN UNKNOWN USER FACILITY IN THE UK. THE INITIAL REPORTER INFORMED (B)(6) ABOUT: "WHEN REMOVING THIS PRODUCT IT CAUSED A SKIN TEAR AND MINOR BLEED TO PATIENTS LEFT LOWER LEG. ECG DOTS ARE VERY STICKY AND WERE DIFFICULT TO REMOVE. LOT NUMBER - 240828-0384 THERE HAVE BEEN 8 OTHER INCIDENTS WHEN REMOVING THIS PRODUCT RESULTING IN SKIN TEARS, PARTIAL SKIN DETACHMENT OR BRUISING TO PATIENTS. PLEASE CAN YOU NOTIFY THE SUPPLIER TO INVESTIGATE WHY REMOVING THIS PRODUCT RESULTS IN PATIENT INJURY." WE HAVE REQUESTED CUSTOMER SAMPLES AND A FILLED IN QUESTIONNAIRE. WE WILL PROVIDE A FOLLOW UP REPORT ONCE WE HAVE RECEIVED ANY FURTHER INFORMATION.
ON (B)(6) 2025, WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING A XLBLEU ECG ELECTRODE REF.: FS-WA01C+/10 (OUR MODEL.: FSVM01/10) AT AN UNKNOWN USER FACILITY IN THE UK. THE INITIAL REPORTER INFORMED (B)(6) ABOUT: "WHEN REMOVING THIS PRODUCT IT CAUSED A SKIN TEAR AND MINOR BLEED TO PATIENTS LEFT LOWER LEG. ECG DOTS ARE VERY STICKY AND WERE DIFFICULT TO REMOVE. LOT NUMBER - 240828-0384 THERE HAVE BEEN 8 OTHER INCIDENTS WHEN REMOVING THIS PRODUCT RESULTING IN SKIN TEARS, PARTIAL SKIN DETACHMENT OR BRUISING TO PATIENTS. PLEASE CAN YOU NOTIFY THE SUPPLIER TO INVESTIGATE WHY REMOVING THIS PRODUCT RESULTS IN PATIENT INJURY." ON (B)(6) 2025 WE HAVE RECEIVED A FANNIN QUESTIONAIRE FORM STATING: "REMOVING ECG DOTS FROM PATIENTS LEGS - CAUSED A SKIN TEAR TO LEFT LOWER LEG. ECG DOTS APPEARED VERY STICKY AND ALL WERE DIFFICULT TO REMOVE. SKIN TEAR CAUSED MINOR BLEED- SOME BLOOD ON CARPET. (...) REMOVED REST OF ECG DOTS WITH WARM WATER. SMALL DRESSING APPLIED TO WOUND. INFORMED WARDEN ON SITE. A PHOTO WAS TAKEN OF SKIN TEAR HAVING OBTAINED THE PATIENTS PERMISSION WHICH IS ON EPR. APOLOGISED TO PATIENT AND CLEANED CARPET." NO INFORMATION ON THE SKIN PREPARATION, THE WEARING TIME AND IF AND HOW THE SKIN INJURY HAS TO BE TREATED PRIOR DRESSINGS AFTERWARDS. WE HAVE REQUESTED CUSTOMER SAMPLES AND A FILLED IN QUESTIONNAIRE BUT NONE HAS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 849806 | XLBLEU | ECG ELECTRODE | DRX | LEONHARD LANG GMBH | FS-VM01 | 240828-0384 | 19005531001453 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |