| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | URINE METER | DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE | FFG | 25001183 | 307324 | N | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-07-25 | 0 |
Patient 1
(B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A PRODUCT MALFUNCTION. NO SERIOUS INJURY WAS REPORTED. ADDITIONAL DETAILS HAVE BEEN REQUESTED BUT NOT PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. (B)(4).
Patient 1
COMPLAINT RECEIVED FROM A HOSPITAL IN (B)(6) REPORTING THAT "THE PROBLEM IS THAT WHEN THEY CONNECTED THE CATHETER TO THE UNOMETER, THE URINE DOES NOT FLOW." CLARIFICATION WAS OBTAINED: REPORTER STATED THAT THE PATIENT EXPERIENCED URINARY RETENTION AND "THE NURSES REALIZED THAT THE CORRECT URINE DESCENT WAS NOT BEING PRODUCED SINCE THEY STARTED USING THE DEVICE. WHEN THEY OBSERVED THIS INCIDENCE, THEY MADE DISCONNECTIONS OF IT FROM THE BLADDER CATHETER OR THEY PRICKED IT TO FAVOR THE AIR ENTRANCE IN THE SYSTEM AND FAVOR THE URINE DESCENT." REPORTER STATED THAT BEFORE THE DEVICE WAS ATTACHED TO THE INDWELLING CATHETER, "THE URINE FLOWED WITHOUT ANY PROBLEM. [HOWEVER], AT THE TIME OF THE PLACEMENT OF THE DEVICE, THE PROFESSIONALS OBSERVED A SIGNIFICANT DECREASE IN THE URINE DESCENT." THE REPORTER VERIFIED THAT THE INDWELLING CATHETER WAS FLUSHED, WAS PATENT AND RETURNED NO CLOTS OR SEDIMENT, BUT URINE DID NOT FLOW. STAFF REPLACED UNIT IN ACCORDANCE WITH HOSPITAL PROTOCOL.