N
Patient 1
(B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.
MAUDE MDR 5555205
- MDR report key
- 5555205
- Report number
- 1820334-2016-00220
- Event key
- 0
- Event type
- 3
- Date received
- 2016-04-07
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MRS. RITA HARDEN
- Address
- 750 DANIELS WAY BLOOMINGTON IN 47404 US
- Phone
- 812-812-8128
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-04-07 | 0 | 1. O |
Event Narratives#
D
Patient 1
ACCORDING TO THE INITIAL REPORTER, AFTER PLACEMENT OF A GOLDSTEIN SONOBIOPSY CATHETER ON A FEMALE PATIENT OF AN UNKNOWN AGE, THE CONE OF THE CATHETER BECAME SEPARATED AND REMAINED IN THE PATIENT UNTIL IT WAS FOUND SEVERAL DAYS LATER BY THE PATIENT'S HUSBAND. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER IT WAS NOT PROVIDED BY THE TIME OF THIS REPORT.
N
Patient 1
(B)(4). INITIAL WAS FILED WITHIN THE 30 DAY TIME FRAME REGARDLESS OF CORRECTED DATE. INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE DEVICE IS SHIPPED WITH AN IFU THAT DESCRIBES THE INTENDED USE, SPECIFIC ITEMS ARE ADDRESSED SUCH AS: UPON REMOVAL OF THE CATHETER, ENSURE THAT POSITIONER IS STILL ON BODY OF CATHETER. IF STILL LODGED IN PATIENT CERVIX, REMOVE USING FORCEPS." THE COMPLAINT DEVICE WAS NOT RETURNED THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. AS INSTRUCTIONS ARE PROVIDED TO CONFIRM REMOVAL OF THE POSITIONER FROM WITHIN THE PATIENT CERVIX, THE ROOT CAUSE HAS BEEN DETERMINED TO BE PRODUCT USE AS THE END USER DID NOT FOLLOW THE INSTRUCTIONS PROVIDED WITH THE PRODUCT. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.
D
Patient 1
ACCORDING TO THE INITIAL REPORTER, AFTER PLACEMENT OF A GOLDSTEIN SONOBIOPSY CATHETER ON A FEMALE PATIENT OF AN UNKNOWN AGE, THE CONE OF THE CATHETER BECAME SEPARATED AND REMAINED IN THE PATIENT UNTIL IT WAS FOUND SEVERAL DAYS LATER BY THE PATIENT?S HUSBAND. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER IT WAS NOT PROVIDED BY THE TIME OF THIS REPORT.