| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | BARDEX I.C. 5CC LATEX FOLEY CATHETER WITH SILVER/HYDROGEL COATING,2-WAY, TWO OPP | FOLEY CATHETER | BARD SDN. BHD. -8040607 | MJC | 0165SI16 | UNK | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-01-24 | 0 |
Patient 1
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. THE DEVICE WAS NOT RETURNED.
Patient 1
IT WAS REPORTED THAT THE CATHETER ALLEGEDLY LEAKED. THE COMPLAINANT STATED THAT CATHETER WAS PLACED BY HER DOCTOR AFTER SURGERY, AND SHE IS UNSURE WHERE THE LEAK IS COMING FROM. NO MEDICAL INTERVENTION WAS REQUIRED. NO PATIENT INJURY WAS REPORTED.
Patient 1
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. THE DEVICE WAS NOT RETURNED.
Patient 1
IT WAS REPORTED THAT THE CATHETER ALLEGEDLY LEAKED. THE COMPLAINANT STATED THAT THE CATHETER WAS PLACED BY HER DOCTOR AFTER SURGERY, AND SHE IS UNSURE WHERE THE LEAK IS COMING FROM. NO MEDICAL INTERVENTION WAS REQUIRED. NO PATIENT INJURY WAS REPORTED.
Patient 1
THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: "RECOMMENDED INFLATION CAPACITIES: A 3CC BALLOON: USE 5CC STERILE WATER, 5CC BALLOON: USE 10CC STERILE WATER, 30CC BALLOON: USE 35CC STERILE WATER." (B)(4). THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. THE DEVICE WAS NOT RETURNED.
Patient 1
IT WAS REPORTED THAT THE CATHETER ALLEGEDLY LEAKED. THE COMPLAINANT STATED THAT THE CATHETER WAS PLACED BY HER DOCTOR AFTER SURGERY, AND SHE IS UNSURE WHERE THE LEAK IS COMING FROM. NO MEDICAL INTERVENTION WAS REQUIRED. NO PATIENT INJURY WAS REPORTED.