FDA Adverse Event Death Summary report: N

INVACARE

MDR report key: 1711644 · Received June 9, 2010

Report

Report Number
MW5016196
Event Type
Death
Date Received
June 9, 2010
Date of Event
July 13, 2008
Report Date
June 1, 2010
Manufacturer
INVACARE
Product Code
FNL
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
NY, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

THE CHILD, (B) (6), STRANGLED TO DEATH ON A BED RAIL AT HIS HOME IN (B) (6). COPIES OF RELEVANT DOCUMENTS INCLUDING THE AUTOPSY REPORT, DEATH CERTIFICATE, PHOTOGRAPHS OF THE SCENE AND BED RAIL, SHERIFF'S REPORT AND EMT RUN REPORT, 01/19/08 REDACTED DISCHARGE SUMMARY FOR SCOLIOSIS OPERATION, AND RECEIPT FOR THE BED FOLLOW UNDER SEPARATE COVER BY REGULAR MAIL. WE ALSO WILL ATTACH A COPY OF THE SUMMONS AND COMPLAINT FILED IN THE STATE COURT LITIGATION FOR (B) (6) DEATH ON (B) (6) 2010. DATES OF USE: (B) (6) 2008 - (B) (6) 2008. DIAGNOSIS OR REASON FOR USE: SCOLIOSIS OPERATION AND FOLLOWUP.

Description of Event or Problem · 1

THE CHILD (B) (6) STRANGLED TO DEATH ON A BED RAIL AT HIS HOME IN (B) (6), (B) (6). COPIES OF RELEVANT DOCUMENTS INCLUDING THE AUTOPSY REPORT, DEATH CERTIFICATE, PHOTOGRAPHS OF THE SCENE AND BED RAIL, SHERIFF'S REPORT AND EMT RUN REPORT, 1/19/08 REDACTED DISCHARGE SUMMARY FOR SCOLIOSIS OPERATION, AND RECEIPT FOR THE BED FOLLOW UNDER SEPARATE COVER BY REGULAR MAIL. WE ALSO WILL ATTACH A COPY OF THE SUMMONS AND COMPLAINT FILED IN THE STATE COURT LITIGATION FOR (B) (6) DEATH ON (B) (6) 2010. DATES OF USE: (B) (6) 2008. (B) (6) 2008. DIAGNOSIS OR REASON FOR USE: SCOLIOSIS OPERATION AND FOLLOW-UP.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 INVACARE BED RAIL FNL INVACARE 6629,5308A

Patients

Seq Age Sex Outcome Treatment
1 11 YR Death