FDA Adverse Event
Death
Summary report: N
DEPEND OVERNIGHT BRIEFS
MDR report key: 37022
·
Received September 11, 1996
Report
- Report Number
- 2183052-1996-00001
- Event Type
- Death
- Date Received
- September 11, 1996
- Date of Event
- July 10, 1996
- Report Date
- August 12, 1996
- Manufacturer
- KIMBERLY-CLARK CORP.
- Product Code
- EYQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
EARLY IN THE MORNING OF 7/10/96 A 17 YEAR OLD MALE WITH CEREBRAL PALSY LIVING AT HOME APPARENTLY CHOKED TO DEATH ON A PIECE OF MATERIAL WHICH HE TORE FROM A DISPOSABLE INCONTINENCE PROTECTIVE GARMENT HE WAS WEARING. THE INDIVIDUAL ONLY WORE INCONTINENCE GARMENTS FOR OVERNIGHT USE AND HE HAD BEEN OBSERVED PICKING AT THE PRODUCT PRIOR TO THE INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEPEND OVERNIGHT BRIEFS | INCONTINENCE PROTECTIVE GARMENT | EYQ | KIMBERLY-CLARK CORP. | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | Death |