N
Patient 1
(B)(4). EVENT IS STILL UNDER INVESTIGATION AT THIS TIME.
MAUDE MDR 5404110
- MDR report key
- 5404110
- Report number
- 1820334-2016-00042
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-01-07
- Date received
- 2016-02-02
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- 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 | 2016-02-02 | 0 | 1. R |
Event Narratives#
D
Patient 1
AT THE END OF AN UNKNOWN PROCEDURE ON A FEMALE PATIENT OF UNKNOWN AGE, THE USER WAS HOLDING THE CATHETER WITH SWABS WHILE REMOVING THE DEVICE. THE RUBBER STOPPER SLID OFF OF THE CATHETER IN THE PATIENT. THE PHYSICIAN WAS ABLE TO EXTRICATE THE PART FROM THE PATIENT. THE CUSTOMER STATED IT SEEMED THERE WAS NOT ENOUGH RESISTANCE FOR THE RUBBER PIECE TO STAY ON THE DEVICE DURING REMOVAL. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
N
Patient 1
(B)(4). INVESTIGATION/EVALUATION: DURING THE COURSE OF THE INVESTIGATION, A REVIEW OF THE COMPLAINT HISTORY, QUALITY CONTROL, INSTRUCTIONS FOR USE (IFU), AND DRAWING OF THE PRODUCT WAS CONDUCTED. IT SHOULD BE NOTED THAT THE POSITIONER IS INTENDED TO BE ADJUSTABLE FOR POSITIONING. THEREFORE, A SMALL MOVEMENT OF THE POSITIONER ON THE TUBING IS EXPECTED. IT IS HIGHLY UNLIKELY THE POSITIONER WOULD SLIDE OFF THE TUBING WITHOUT AN EXTRANEOUS FORCE APPLIED. THE PROVIDED INSTRUCTIONS FOR USE (IFU) STATES, "UPON REMOVAL OF CATHETER, ENSURE THAT POSITIONER IS STILL ON BODY OF CATHETER. IF STILL LODGED IN PATIENT CERVIX, REMOVE USING FORCEPS.". IF THE POSITIONER SHOULD FALL OFF OF THE CATHETER DURING THE PROCEDURE, THE END USER IS INSTRUCTED TO REMOVE THE SEPARATED SECTION WITH FORCEPS. THE PRODUCT WAS NOT RETURNED FOR A PHYSICAL EXAMINATION. THE PROVIDED INSTRUCTIONS FOR USE CAUTION THAT THE SILICONE POSITIONER MAY FALL OFF DURING REMOVAL AND PROVIDES INSTRUCTION AS TO WHAT TO DO IN THAT SITUATION. PER THE RISK ASSESSMENT (RA) NO FURTHER ACTION IS REQUIRED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.
D
Patient 1
AT THE END OF AN UNKNOWN PROCEDURE ON A FEMALE PATIENT OF UNKNOWN AGE, THE USER WAS HOLDING THE CATHETER WITH SWABS WHILE REMOVING THE DEVICE. THE RUBBER STOPPER SLID OFF OF THE CATHETER IN THE PATIENT. THE PHYSICIAN WAS ABLE TO EXTRICATE THE PART FROM THE PATIENT. THE CUSTOMER STATED IT SEEMED THERE WAS NOT ENOUGH RESISTANCE FOR THE RUBBER PIECE TO STAY ON THE DEVICE DURING REMOVAL. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.