N
Patient 1
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.
MAUDE MDR 8189743
- MDR report key
- 8189743
- Report number
- 1018233-2018-06135
- Event key
- 0
- Event type
- 3
- Date received
- 2018-12-21
- 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
- YONIC ANDERSON
- Address
- 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US
- Phone
- 770-770-7707
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | DILATION PRODUCTS | DILATION PRODUCTS | C.R. BARD, INC. (COVINGTON) -1018233 | FBW | UNKNOWN | UNK | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-12-21 | 0 | 1. R |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT A FEMALE PATIENT HAD A PERCUTANEOUS NEPHROSTOLITHOTOMY WHERE AN X-FORCE NEPHROSTOMY BALLOON DILATING CATHETER WAS USED ON (B)(6) 2018. A CT SCAN ON (B)(6) 2018 WAS BEING COMPLETED FOR OTHER MEDICAL REASONS NOT RELATED. THE SCAN REVEALED A FOREIGN BODY WHICH WAS ASYMPTOMATIC TO THE PATIENT AND WAS A COINCIDENTAL FINDING ON CT SCAN. A URETEROSCOPY SHOWED WHAT APPEARED TO BE PART OF A SHEATH MEASURING 7X7MM WHICH WAS NOT COLLAPSIBLE OR FOLDABLE AND COULD NOT BE REMOVED DURING THE URETEROSCOPY. THE FOREIGN BODY WAS REMOVED PERCUTANEOUSLY. A DOUBLE-J STENT AND FOLEY CATHETER WAS LEFT IN PLACE AFTER THE FOREIGN BODY REMOVAL. THE PATIENT WAS ADMITTED ON (B)(6) 2018 AS A 23 HOUR OBSERVATION PATIENT, POST FOREIGN BODY REMOVAL AND STARTED ON CEPHALEXIN 500 MG BY MOUTH THREE TIMES A DAY AND CONTINUED ON THE SAME ANTIBIOTIC AT DISCHARGE FROM HOSPITAL ADMISSION. THE PATHOLOGY REPORT GROSS EXAMINATION OF THE FOREIGN OBJECT WAS AS FOLLOWS, "IT IS A 0.9 X 0.6 X 0.1 CM CURVILINEAR PORTION OF PLASTIC HAVING A LIME GREEN COLORED OUTER DIAMETER AND A TAN-LIGHT BLUE COLORED INNER DIAMETER."