FDA Adverse Event Malfunction Summary report: N

WATER PIK SONIC FUSION FLOSSING TOOTHBRUSH

MDR report key: 10550819 · Received September 17, 2020

Report

Report Number
0001712259-2020-00006
Event Type
Malfunction
Date Received
September 17, 2020
Date of Event
September 16, 2020
Report Date
September 17, 2020
Manufacturer
WATER PIK INC
Product Code
EFS
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

CLAIM INITIATED BY NATIONAL SUBROGATION SERVICES AND COMMUNICATED TO SONIC FUSION RECALL INBOX [email protected]. SUBROGATION CORRESPONDENCE CLAIMS SMOKE/FIRE DAMAGE IN MULTIPLE AREAS OF HOUSEHOLD. NO PERSONAL INJURY COMMUNICATED IN CLAIM. PER "INDEPENDENT EXPERT REPORT" ((B)(6) FORENSIC ENGINEERING) IT WAS CONCLUDED "AN ELECTRICAL FAILURE WITHIN THE WATER PIK ELECTRIC TOOTHBRUSH BASE, WHICH HAS BEEN RECALLED THROUGH THE FDA AS A POTENTIAL FIRE AND SPARKING HAZARD; CANNOT BE ELIMINATED AS THE IGNITION SOURCE FOR THE LOSS DATE FIRE." SONIC FUSION RECALL PACKET ISSUED 7/3/2018 AND 7/30/2018 ((B)(6) TRACKING (B)(4), (B)(6) TRACKING (B)(4))-AGENT NOTES ATTACHED TO 7/30/2018 INTERACTION INDICATE "CUSTOMER ON VACATION UNTIL SEP. HAVE NOT RCVS SF UNIT BACK YET." (B)(6) CONTACTED CUSTOMER SERVICE 2/1/2019 AFTER CLAIMED DATE OF LOSS (12/29/2018) ASKING IF DEVICE (SF-02C1804112{SIC}AP) IS SAFE ((B)(6) ASKS VERBATIM IF "THAT MEANS IT WAS MANUFACTURED IN APRIL 12, 2018"). (B)(6) WAS EVASIVE IN DESCRIBING HOW HE CAME TO OWN THE DEVICE; "JUST CAME ACROSS IT." DURING THE CALL, (B)(6) IDENTIFIES (B)(6) AS PURCHASER, LATER REFERS TO (B)(6) AS THE "OWNER." (B)(6) INDICATES HE "DOESN'T NECESSARILY WANT TO RETURN IT," REFUSES RETURN LABEL. (B)(6) CLAIMS HE "WILL CHECK WITH THE ACTUAL OWNER WHETHER HE WANTS TO RETURN IT OR NOT. REP URGES THAT OWNER SHOULD RETURN IT, (B)(6) IDENTIFIES "HE WON'T USE IT" REFERRING TO OWNER. CUSTOMER SERVICE HAS ATTEMPTED TO CONTACT (B)(6) MULTIPLE TIMES WITH NO RESPONSE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1016290 WATER PIK SONIC FUSION FLOSSING TOOTHBRUSH ORAL IRRIGATOR EFS WATER PIK INC SF-02CD012-3 180412AP

Patients

Seq Age Sex Outcome Treatment
1 35 YR Other