STABLE BASE
Report
- Report Number
- 8020045-2019-00031
- Event Type
- Injury
- Date Received
- December 10, 2019
- Report Date
- January 22, 2020
- Manufacturer
- LEONHARD LANG GMBH
- Product Code
- DRX
- PMA / PMN Number
- K023503
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 003
Narratives
RETAINED SAMPLES OF THE 10 DIFFERENT LOTS/BATCHES OF MODEL SBT601 [DI PORTION: (01)10861779000281 ] (180326-0253, 180328-0254, 180419-0158, 180420-0159, 190205-0156, 190206-0157, 190208-0158, 190212-0159, 190214-0151, 190307-0254) AND 15 DIFFERENT LOTS/BATCHES OF MODEL SBW601 [DI PORTION: (01)10861779000274] (190110-0258, 190114-0259, 190116-0251, 190117-0252, 190201-0258, 190213-0071, 190214-0072, 190215-0152, 190218-0073, 190219-0074, 190219-0153, 190306-0073, 190308-0074, 190313-0076, 190325-0073) HAVE BEEN INSPECTED VISUALLY. MECHANICAL TESTS WERE PERFORMED ON 4 RETAINED SAMPLES OF EACH LOT NUMBER. ALL TESTED SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS COULD BE DETECTED. NO INFORMATION ON SKIN TYPE, STATE OF SKIN, WHETHER ANY MEDICATION WAS BEING TAKEN, WHICH MIGHT HAVE A SKIN WEAKENING EFFECT, AND HOW THE SKIN WAS PREPARED BEFORE APPLICATION OF THE ELECTRODES WAS PROVIDED. WE HAVE REQUESTED FURTHER INFORMATION ON EACH OF THE EVENTS. THE COMPLAINTS WERE GATHERED BY ONE TIER-3 DISTRIBUTORS OVER A PERIOD OF 4 MONTHS AND SUBMITTED TO OUR DISTRIBUTOR. THIS COMPLAINT HAS TO BEE SEEN IN CONNECTION TO THREE EARLIER COMPLAINTS ORIGINATING FROM THE SAME TIER-3 DISTRIBUTOR (REPORTED AS MDR 8020045-2018-00026, MDR 8020045-2019-00007 AND 8020045-2019-00018). WE GET 1-2 SKIN REACTION COMPLAINTS A MONTH IN AVERAGE FOR AN ANNUAL QUANTITY OF HALF A BILLION ELECTRODES SOLD. WE DO NOT HAVE ANY OTHER CASE OF A CUSTOMER WITH SUCH A NUMBER OF CASES OF SKIN REACTIONS. THE RECENTLY RECEIVED NUMBER OF CASES (70 FOR A PERIOD OF FOUR MONTHS) FOR THIS TIER-3 DISTRIBUTOR INDICATES AN AGGREGATE OF APPROXIMATELY 200 A YEAR FOR THEM. EVEN WHEN WE BREAK IT DOWN TO THE SPECIFIC MODELS LISTED IN THE COMPLAINTS, THE RATIO DOES NOT MAKE SENSE. WE HAVE MADE MORE THAN 20 MILLION OF MODELS T-601 AND W-601 IN 2018. 3,5 MILLION OF THESE WERE PRIVATE LABELED FOR A TIER-2 DISTRIBUTOR. WE DO NOT KNOW, HOW MANY OF THEM WENT ON TO THE TIER-3 DISTRIBUTOR. HOWEVER, EVEN IF THEY ALL DID, WE'D BE SEEING ALL CASES OF SKIN IRRITATION REPORTED ORIGINATING FROM ABOUT 17% OF THE TOTAL NUMBER OF PRODUCTS AND NONE IN 2018 FROM OTHER CUSTOMERS (REPRESENTING 83% OF THE PRODUCTS). WE THEREFORE ASSUME THAT AN ADDITIONAL PARAMETER OR CIRCUMSTANCES YET UNKNOWN ARE CAUSAL FOR THE INCREASED INCIDENCE OF SKIN IRRITATIONS. WE HAVE REQUESTED ADDITIONAL INFORMATION TO CONDUCT FURTHER INVESTIGATIONS AND WILL REPORT ANY FINDINGS IN A FOLLOW-UP REPORT.
RETAINED SAMPLES OF THE 10 DIFFERENT LOTS/BATCHES OF MODEL SBT601 [DI PORTION: (01)10861779000281 ] (180326-0253, 180328-0254, 180419-0158, 180420-0159, 190205-0156, 190206-0157, 190208-0158, 190212-0159, 190214-0151, 190307-0254) AND 15 DIFFERENT LOTS/BATCHES OF MODEL SBW601 [DI PORTION: (01)10861779000274] (190110-0258, 190114-0259, 190116-0251, 190117-0252, 190201-0258, 190213-0071, 190214-0072, 190215-0152, 190218-0073, 190219-0074, 190219-0153, 190306-0073, 190308-0074, 190313-0076, 190325-0073) HAVE BEEN INSPECTED VISUALLY. MECHANICAL TESTS WERE PERFORMED ON 4 RETAINED SAMPLES OF EACH LOT NUMBER. ALL TESTED SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS COULD BE DETECTED. NO INFORMATION ON SKIN TYPE, STATE OF SKIN, WHETHER ANY MEDICATION WAS BEING TAKEN, WHICH MIGHT HAVE A SKIN WEAKENING EFFECT, AND HOW THE SKIN WAS PREPARED BEFORE APPLICATION OF THE ELECTRODES WAS PROVIDED. WE HAVE REQUESTED FURTHER INFORMATION ON EACH OF THE EVENTS. THE COMPLAINTS WERE GATHERED BY ONE TIER-3 DISTRIBUTORS OVER A PERIOD OF 4 MONTHS AND SUBMITTED TO OUR DISTRIBUTOR. THIS COMPLAINT HAS TO BEE SEEN IN CONNECTION TO THREE EARLIER COMPLAINTS ORIGINATING FROM THE SAME TIER-3 DISTRIBUTOR (REPORTED AS MDR 8020045-2018-00026, MDR 8020045-2019-00007 AND 8020045-2019-00018). WE GET 1-2 SKIN REACTION COMPLAINTS A MONTH IN AVERAGE FOR AN ANNUAL QUANTITY OF HALF A BILLION ELECTRODES SOLD. WE DO NOT HAVE ANY OTHER CASE OF A CUSTOMER WITH SUCH A NUMBER OF CASES OF SKIN REACTIONS. THE RECENTLY RECEIVED NUMBER OF CASES (70 FOR A PERIOD OF FOUR MONTHS) FOR THIS TIER-3 DISTRIBUTOR INDICATES AN AGGREGATE OF APPROXIMATELY 200 A YEAR FOR THEM. EVEN WHEN WE BREAK IT DOWN TO THE SPECIFIC MODELS LISTED IN THE COMPLAINTS, THE RATIO DOES NOT MAKE SENSE. WE HAVE MADE MORE THAN 20 MILLION OF MODELS T-601 AND W-601 IN 2018. 3,5 MILLION OF THESE WERE PRIVATE LABELED FOR A TIER-2 DISTRIBUTOR. WE DO NOT KNOW, HOW MANY OF THEM WENT ON TO THE TIER-3 DISTRIBUTOR. HOWEVER, EVEN IF THEY ALL DID, WE'D BE SEEING ALL CASES OF SKIN IRRITATION REPORTED ORIGINATING FROM ABOUT 17% OF THE TOTAL NUMBER OF PRODUCTS AND NONE IN 2018 FROM OTHER CUSTOMERS (REPRESENTING 83% OF THE PRODUCTS). WE THEREFORE ASSUME THAT AN ADDITIONAL PARAMETER OR CIRCUMSTANCES YET UNKNOWN ARE CAUSAL FOR THE INCREASED INCIDENCE OF SKIN IRRITATIONS. AS NO FURTHER INFORMATION WAS AVAILABLE DESPITE REPEATED REQUESTS FOR THE ALREADY EXISTING INCIDENTS WE HAVE DESIGNED A NEW QUESTIONNAIRE TAYLORED TO THE CUSTOMER'S SPECIAL USE MODEL. WITH THE NEW QUESTIONAIRE, WE ARE CONFIDENT TO RECEIVE IMPROVED INFORMATION ON FUTURE INCIDENTS TO BE ABLE TO DETERMINE A ROOT CAUSE. HOWEVER AS NO FURTHER INFORMATION WAS MADE AVAILBE ON THE INCIDENTS COVERED IN THIS REPORT, NO CONCLUSION CAN BE DRAWN WHAT MIGHT HAVE CAUSED THE CUSTOMERS PROBLEMS. WE CONSIDER THE INVESTIGATION CLOSED AND WILL ONLY RESUME IT WHEN NEW CASES ARE REPORTED. WE WOULD COVER THEM UNDER A NEW MDR.
ON (B)(6)2019, WE HAVE BEEN INFORMED ABOUT SEVERAL INCIDENTS WITH ECG ELECTRODES. MONITORING ECG ELECTRODES (MODEL SBW601 AND SBT601) HAD BEEN USED WITH VARIOUS VERITE, BG MINI AND BGH DEVICES. THE INITIAL REPORT STATED THAT "PATIENTS REPORTED SEVERE SKIN IRRITATION WITH OPEN SORES AND/OR BLEEDING. THERE WERE 70 ACCOUNTS FROM MAY 2019 - AUGUST 2019. SOME PATIENTS DISCONTINUED USE TO AWAIT HEALING OR MORE INFORMATION FROM PHYSICIANS AND OTHERS WERE SENT ELECTRODES THAT ARE MORE SENSITIVE, IF POSSIBLE, TO TRY." THE REPORT REFERRED TO 70 SEPARATE CASES, INVOLVING A TOTAL OF 10 DIFFERENT LOT/BATCHES OF MODEL SBT601 AND 15 DIFFERENT LOT/BATCHES OF MODEL SBW601 . NO FURTHER INFORMATION WAS PROVIDED IF AND HOW THE INJURIES HAD TO BEEN TREATED AFTER THE PROCEDURE.
ON (B)(6) 2019, WE HAVE BEEN INFORMED ABOUT SEVERAL INCIDENTS WITH ECG ELECTRODES. MONITORING ECG ELECTRODES (MODEL SBW601 AND SBT601) HAD BEEN USED WITH VARIOUS VERITE, BG MINI AND BGH DEVICES. THE INITIAL REPORT STATED THAT "PATIENTS REPORTED SEVERE SKIN IRRITATION WITH OPEN SORES AND/OR BLEEDING. THERE WERE 70 ACCOUNTS FROM (B)(6) 2019. SOME PATIENTS DISCONTINUED USE TO AWAIT HEALING OR MORE INFORMATION FROM PHYSICIANS AND OTHERS WERE SENT ELECTRODES THAT ARE MORE SENSITIVE, IF POSSIBLE, TO TRY." THE REPORT REFERRED TO 70 SEPARATE CASES, INVOLVING A TOTAL OF 10 DIFFERENT LOT/BATCHES OF MODEL SBT601 AND 15 DIFFERENT LOT/BATCHES OF MODEL SBW601 . NO FURTHER INFORMATION WAS PROVIDED IF AND HOW THE INJURIES HAD TO BEEN TREATED AFTER THE PROCEDURE.
RETAINED SAMPLES OF THE 10 DIFFERENT LOTS/BATCHES OF MODEL SBT601 [DI PORTION: (B)(4)] (180326-0253, 180328-0254, 180419-0158, 180420-0159, 190205-0156, 190206-0157, 190208-0158, 190212-0159, 190214-0151, 190307-0254) AND 15 DIFFERENT LOTS/BATCHES OF MODEL SBW601 [DI PORTION: (B)(4)] (190110-0258, 190114-0259, 190116-0251, 190117-0252, 190201-0258, 190213-0071, 190214-0072, 190215-0152, 190218-0073, 190219-0074, 190219-0153, 190306-0073, 190308-0074, 190313-0076, 190325-0073) HAVE BEEN INSPECTED VISUALLY. MECHANICAL TESTS WERE PERFORMED ON 4 RETAINED SAMPLES OF EACH LOT NUMBER. ALL TESTED SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS COULD BE DETECTED. NO INFORMATION ON SKIN TYPE, STATE OF SKIN, WHETHER ANY MEDICATION WAS BEING TAKEN, WHICH MIGHT HAVE A SKIN WEAKENING EFFECT, AND HOW THE SKIN WAS PREPARED BEFORE APPLICATION OF THE ELECTRODES WAS PROVIDED. WE HAVE REQUESTED FURTHER INFORMATION ON EACH OF THE EVENTS. THE COMPLAINTS WERE GATHERED BY ONE TIER-3 DISTRIBUTORS OVER A PERIOD OF 4 MONTHS AND SUBMITTED TO OUR DISTRIBUTOR. THIS COMPLAINT HAS TO BEE SEEN IN CONNECTION TO THREE EARLIER COMPLAINTS ORIGINATING FROM THE SAME TIER-3 DISTRIBUTOR (REPORTED AS MDR 8020045-2018-00026, MDR 8020045-2019-00007 AND 8020045-2019-00018). WE GET 1-2 SKIN REACTION COMPLAINTS A MONTH IN AVERAGE FOR AN ANNUAL QUANTITY OF HALF A BILLION ELECTRODES SOLD. WE DO NOT HAVE ANY OTHER CASE OF A CUSTOMER WITH SUCH A NUMBER OF CASES OF SKIN REACTIONS. THE RECENTLY RECEIVED NUMBER OF CASES (70 FOR A PERIOD OF FOUR MONTHS) FOR THIS TIER-3 DISTRIBUTOR INDICATES AN AGGREGATE OF APPROXIMATELY 200 A YEAR FOR THEM. EVEN WHEN WE BREAK IT DOWN TO THE SPECIFIC MODELS LISTED IN THE COMPLAINTS, THE RATIO DOES NOT MAKE SENSE. WE HAVE MADE MORE THAN 20 MILLION OF MODELS T-601 AND W-601 IN 2018. 3,5 MILLION OF THESE WERE PRIVATE LABELED FOR A TIER-2 DISTRIBUTOR. WE DO NOT KNOW, HOW MANY OF THEM WENT ON TO THE TIER-3 DISTRIBUTOR. HOWEVER, EVEN IF THEY ALL DID, WE'D BE SEEING ALL CASES OF SKIN IRRITATION REPORTED ORIGINATING FROM ABOUT 17% OF THE TOTAL NUMBER OF PRODUCTS AND NONE IN 2018 FROM OTHER CUSTOMERS (REPRESENTING 83% OF THE PRODUCTS). WE THEREFORE ASSUME THAT AN ADDITIONAL PARAMETER OR CIRCUMSTANCES YET UNKNOWN ARE CAUSAL FOR THE INCREASED INCIDENCE OF SKIN IRRITATIONS. WE HAVE REQUESTED ADDITIONAL INFORMATION TO CONDUCT FURTHER INVESTIGATIONS AND WILL REPORT ANY FINDINGS IN A FOLLOW-UP REPORT.
ON (B)(6) 2019, WE HAVE BEEN INFORMED ABOUT SEVERAL INCIDENTS WITH ECG ELECTRODES. MONITORING ECG ELECTRODES (MODEL SBW601 AND SBT601) HAD BEEN USED WITH VARIOUS VERITE, BG MINI AND BGH DEVICES. THE INITIAL REPORT STATED THAT "PATIENTS REPORTED SEVERE SKIN IRRITATION WITH OPEN SORES AND/OR BLEEDING. THERE WERE 70 ACCOUNTS FROM (B)(6) 2019 - (B)(6) 2019. SOME PATIENTS DISCONTINUED USE TO AWAIT HEALING OR MORE INFORMATION FROM PHYSICIANS AND OTHERS WERE SENT ELECTRODES THAT ARE MORE SENSITIVE, IF POSSIBLE, TO TRY." THE REPORT REFERRED TO 70 SEPARATE CASES, INVOLVING A TOTAL OF 10 DIFFERENT LOT/BATCHES OF MODEL SBT601 AND 15 DIFFERENT LOT/BATCHES OF MODEL SBW601 . NO FURTHER INFORMATION WAS PROVIDED IF AND HOW THE INJURIES HAD TO BEEN TREATED AFTER THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1238743 | STABLE BASE | ECG ELECTRODE | DRX | LEONHARD LANG GMBH | W-601 | 190213-0071 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death| O |