D
Patient 1
IT WAS REPORTED THAT THE CATHETER CAUSED THE USER TO EXPERIENCE LOSS OF 4 PINTS OF BLOOD INTO THE BAG, (B)(6). WEIGHT LOSS AND INFECTION. USER STATED THAT THE PHYSICIAN DID NOT USE PVP BETADINE WHEN INSERTING THE CATHETER.
MAUDE MDR 4275225
- MDR report key
- 4275225
- Report number
- 1018233-2014-00301
- Event key
- 0
- Event type
- 3
- Date received
- 2014-11-07
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- CHRISTY LEWIS
- 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 | BARDIA 5CC SILICONE-COATED LATEX FOLEY CATHETER | BARD SDN. BHD. | EZC | NA | 123516A | UNK | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-11-07 | 0 | 1. R |
Event Narratives#
N
Patient 1
THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNK; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. (B)(4).