N
Patient 1
THE EVALUATION OF THIS ISSUE IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
MAUDE MDR 8093603
- MDR report key
- 8093603
- Report number
- 1625425-2018-00186
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-10-04
- Date received
- 2018-11-21
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. GAIL SMITH
- Address
- 1445 FLAT CREEK ROAD ATHENS TX 75751 US
- Phone
- 214-214-2144
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SKATER? SINGLE-STEP DRAINAGE CATHETER SET WITH LOCKING PIGTAIL | DRAINAGE CATHETERS | ARGON MEDICAL DEVICES INC. | GBQ | 756506025 | 11207840 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-11-21 | 0 | 1. O |
Event Narratives#
D
Patient 1
DUE TO RESISTANCE, IT WAS NOT ABLE TO PULL THE THREAD OUT WHEN REMOVING THE CATHETER AFTER DRAINAGE OF ONE MONTH PERIOD. THE THREAD WAS CUT CLOSE TO THE SKIN SURFACE AND THE REMAINING THREAD WAS LEFT IN THE PATIENT BODY. THE CATHETER HAD PLACED IN A GAL BALDER FOR A MONTH FOR DRAINAGE. NO EXTRA PROCEDURE OR SURGERY IS PLANED TO REMOVE THE REMAINING THREAD FROM THE BODY.