DEPEND UNDERGARMENTS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ
Report
- Report Number
- 2184163-2019-00007
- Event Type
- Injury
- Date Received
- August 6, 2019
- Date of Event
- July 13, 2019
- Report Date
- December 20, 2019
- Manufacturer
- NEENAH COLD SPRING FACILITY
- Product Code
- EYQ
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- 003
Narratives
DURING THE COURSE OF KIMBERLY-CLARK¿S INVESTIGATION OF THIS COMPLAINT, KIMBERLY-CLARK OBTAINED INFORMATION SUGGESTING THAT THE SUBJECT OF THE COMPLAINT MAY HAVE PASSED AWAY MORE THAN A YEAR PRIOR TO THE DATE OF THE REPORTED EVENT. A COPY OF THE REGISTERED DEATH CERTIFICATE FOR THE CONSUMER WAS OBTAINED FROM THE PROVINCE OF ONTARIO VITAL STATISTICS DEATH REGISTRY. THE DATE OF DEATH FOR THE CONSUMER WAS RECORDED AS (B)(6) 2018, WHICH WAS APPROXIMATELY MORE THAN A YEAR PRIOR TO THE DATE OF THE EVENTS AS REPORTED BY THE COMPLAINANT.
NEW AND CORRECTED INFORMATION: B5: THIS IS A FOLLOW UP TO REPORT ADDITIONAL INFORMATION RECEIVED AND TO CORRECT THE H6 DEVICE CODE FROM 1562 TO 2993. WE HAVE BEEN INFORMED BY THE CONSUMER'S DAUGHTER THAT CONSUMER HAD BEEN RELEASED FROM THE HOSPITAL. CONSUMER'S DAUGHTER REPORTED HER MOTHER WAS BEDRIDDEN AND WHILE AT HOME ON AN UNSPECIFIED DATE HER MOTHER FELL AND FRACTURED HER LEG. SHE WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL WHERE HER HEALTH WAS REPORTED TO DECLINE. SHE PASSED AWAY ON (B)(6) 2019. OUR MEDICAL ASSESSMENT HAS DETERMINED THE DEATH OF THE CONSUMER WAS NOT AN OUTCOME OF THE REPORTED ADVERSE EVENT. H6: PATIENT CODE AND DEVICE CODE (REMOVED 1562 AND ADDED 2993).
THIS IS A FOLLOW UP TO REPORT ADDITIONAL INFORMATION RECEIVED IN H10.
THIS IS A FOLLOW UP TO REPORT ADDITIONAL INFORMATION RECEIVED AND TO CORRECT THE H6 DEVICE CODE FROM 1562 TO 2993. WE HAVE BEEN INFORMED BY THE CONSUMER'S DAUGHTER THAT CONSUMER HAD BEEN RELEASED FROM THE HOSPITAL. CONSUMER'S DAUGHTER REPORTED HER MOTHER WAS BEDRIDDEN AND WHILE AT HOME ON AN UNSPECIFIED DATE HER MOTHER FELL AND FRACTURED HER LEG. SHE WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL WHERE HER HEALTH WAS REPORTED TO DECLINE. SHE PASSED AWAY ON (B)(6) 2019. OUR MEDICAL ASSESSMENT HAS DETERMINED THE DEATH OF THE CONSUMER WAS NOT AN OUTCOME OF THE REPORTED ADVERSE EVENT.
A MANUFACTURER LOT CODE WAS NOT PROVIDED. WITH NO MEANS TO ASCERTAIN THE MANUFACTURER/ASSET LINE AND DAY OF PRODUCTION, NO FURTHER INVESTIGATION ON DOCUMENTS AND SUPPORTING RECORDS CAN BE PERFORMED. NO NATURAL RUBBER LATEX IS USED IN DEPEND® SILHOUETTE® BRIEFS FOR WOMEN.
THIS IS A NON-US EVENT. THIS OCCURRED IN (B)(6). CONSUMER¿S DAUGHTER CALLED TO REPORT HER MOTHER TRIED DEPEND SILHOUETTE MAXIMUM SIZE L/XL LAVENDER BRIEFS FOR THE FIRST TIME. AS SOON AS SHE PUT THE PRODUCT ON SHE EXPERIENCED DIFFICULTY BREATHING. TEN MINUTES LATER SHE DEVELOPED HIVES TO HER GENITAL AREA THAT QUICKLY SPREAD TO HER CHEST AND ARMS. SHE WENT INTO ANAPHYLACTIC SHOCK AND HER DAUGHTER ADMINISTERED EPINEPHRINE PEN INJECTION. SHE WAS TAKEN TO THE HOSPITAL BY AMBULANCE AND GIVEN MORE IV EPINEPHRINE. SHE WAS ALSO ADMINISTERED IV BENADRYL AND IV ATARAX. HER BREATHING WAS BACK TO NORMAL WITHIN A DAY. SHE WAS CURRENTLY IN ICU AND TRANSFERRING TO A REGULAR HOSPITAL BED. HIVES WERE IMPROVING. SHE NOW HAS BLOOD CLOTS FROM LAYING IN ICU BED. SINCE SHE HAS A HISTORY OF DIABETES TYPE 2, SHE WAS ALSO RECEIVING IV INSULIN WHILE IN ICU.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 659776 | DEPEND UNDERGARMENTS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ | GARMENT, PROTECTIVE, FOR INCONTINENCE | EYQ | NEENAH COLD SPRING FACILITY | SILHOUETTE FOR WOMEN, L/XL, MAXIMUM ABSORBENCY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 90 YR | Hospitalization| L |