| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | TBD | FFG | 509047 | 227856 | N | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-02-14 | 0 |
Patient 1
BRAND NAME: UNOMETER SAFETI; COMMON DEVICE NAME: DEVICE URINE FLOW RATE MEASURING, NON-ELECTRICAL; PROCODE: FFG. (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A PRODUCT MALFUNCTION. NO PATIENT HARM 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 REPORTED BY A DOCTOR THAT "THE URINE DID NOT FLOW INTO THE COLLECTION ROOM" OF THE DEVICE. THE DEVICE WAS REMOVED. NO FURTHER INFORMATION WAS AVAILABLE.
Patient 1
(B)(4). A BATCH RECORD REVIEW WAS PERFORMED; AND A NON-CONFORMANCE (NC) FROM A PREVIOUS COMPLAINT WAS OPENED WHICH IS ASSOCIATED WITH THIS REPORTED ISSUE. THE NC HAS BEEN CLOSED AND NO FURTHER INVESTIGATION IS REQUIRED. THE INVESTIGATION CONCLUDED THAT THE LIKELY ROOT CAUSE FOR THE ISSUE, "STOP FLOW BETWEEN PATIENT AND CHAMBER OF THE UNOMETER PRODUCT" CANNOT BE IDENTIFIED BASED ON THE INFORMATION RECEIVED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. NO ADDITIONAL PATIENT/DETAILS HAS BEEN PROVIDED REGARDING THE REPORTED EVENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AT A LATER DATE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).