FDA Adverse Event Death Summary report: N

UNK

MDR report key: 3770583 · Received April 9, 2014

Report

Report Number
3770583
Event Type
Death
Date Received
April 9, 2014
Date of Event
March 27, 2014
Report Date
April 7, 2014
Manufacturer
UNK
Product Code
KWA
Report Source
User Facility report
Reporter Location
TX, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

A (B)(6) YR OLD, MALE PATIENT WAS TRANSFERRED FROM (B)(6) EMERGENCY ROOM, LOCATED IN (B)(6)'S EMERGENCY ROOM FOR A HIGHER LEVEL OF CARE ON (B)(6) 2014 AT APPROXIMATELY 1900 HRS. CHIEF COMPLAINT WAS SUSPECTED COBALT INTOXICATION RELATED TO A HIP REPLACEMENT DEVICE. PATIENT ALSO HAD OTHER SERIOUS HEALTH CONDITIONS ATTRIBUTING TO HIS CONDITION, SUCH AS KIDNEY DISEASE ESRD ON HEMODIALYSIS AND HYPERTENSION. IN ADDITION, PATIENT PRESENTED WITH A SKIN RASH THROUGHOUT HIS BODY. PATIENT WAS ADMITTED TO ICU ON (B)(6) 2014, AT 0245 HRS. PATIENT'S CONDITION CONTINUED TO DETERIORATE AND PATIENT WAS INTUBATED. LATER THAT DAY, PATIENT'S FAMILY MADE THE DECISION TO REMOVE THE PATIENT FROM LIFE SUPPORT AT 2210 HRS. MEDICAL EXAMINER DETERMINED THAT THIS WAS NOT AN ME CASE AND BODY WAS RELEASED TO A FUNERAL HOME ON (B)(6) 2014. THE SUSPECTED COBALT INTOXICATION DUE TO THE HIP REPLACEMENT DEVICE WAS RULED OUT IN DEATH PRONOUNCEMENT; HOWEVER, REPORTING ISSUE BECAUSE OF DOCUMENTATION FOR "SUSPECTED COBALT INTOXICATION" AT TIME OF ADMISSION. (B)(6), RN DID SPEAK WITH PATIENT'S SISTER WHO STATED THAT THE HIP REPLACEMENT HAD BEEN DONE MANY YEARS AGO. (B)(6) CONTACTED FOR DEVICE INFORMATION, HOWEVER, NO RECORD OF SURGERY FOR HIP REPLACEMENT AT THAT FACILITY ACCORDING TO THEIR NURSING SUPERVISOR, (B)(6), RN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
215863 UNK HIP REPLACEMENT DEVICE KWA UNK UNK UNK

Patients

Seq Age Sex Outcome Treatment
1 62 YR Death