FDA Adverse Event Injury Summary report: N

SOFT SHELL HELMET

MDR report key: 8044 · Received April 11, 1994

Report

Report Number
8044
Event Type
Injury
Date Received
April 11, 1994
Date of Event
March 29, 1994
Report Date
April 8, 1994
Manufacturer
DANMAR PRODUCTS, INC.
Product Code
FXZ
Adverse Event
Yes
Report Source
User Facility report

Narratives

Description of Event or Problem · 1

ON 3/29/94, AT 7:38 PM THE PT WAS FOUND BY AN LVN IN THE BATHROOM ON THE DORMITORY. HER RIGHT ARM WAS DOWN IN THE TOILET, AND SHE WAS OBSERVED KNEELING ON THE FLOOR. HER COLOR WAS BLUE AND TEMPERATURE WAS COLD. THE STRAP ON THE PROTECTIVE HELMENT SHE WAS WEARING APPEARS TO HAVE BEEN HUNG ON THE FLUSHING HANDLE OF THE TOILET. THE STRAP WAS LOOSENED, PT LAYED ON THE FLOOR, AND CPR BEGAN. EMS ARRIVED AT 7:50 PM, PULSE NOTED AT 8:09 PM. AT 8:15 PM EMS TRANSPORTED HER TO LOCAL HOSP. PT DIED AT HOSP AT 9:40 AM ON 3/30/94.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE, USER EDUCATION PROVIDED, INSERVICED BY OTHER FACILITY STAFF. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SOFT SHELL HELMET SOFT SHELL HELMET FXZ DANMAR PRODUCTS, INC. 9820

Patients

Seq Age Sex Outcome Treatment
1 37 YR Required Intervention