MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-21 for TBD 158101010190 manufactured by Unomedical Zavodskaya Street 50.
[182707674]
Mdr 3007966929-2020-00008 / device 1 of 1. Brand name: urine meter. (b)(6). Date of manufacture: 02/2019. Based on the available information, this event is deemed to be a reportable malfunction. To date no additional information has been received. Should additional information become available, a follow-up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[182707675]
It was reported that the product caused a "bladder globe due to failed urine outflow. Due to this patient referred abdominal pain. " upon clarification a bladder globe is "an abnormal distension of the bladder due to the increase in the volume of urine contained therein secondary to acute urinary retention. The bladder globe is associated with suprapubic pain and reduced bladder contractility". It was reported by the user facility that the patient did have urine present in the catheter, however a bladder scan was done and there was "500 ml" noted within the bladder. Per the user facility the product placement was "positioned correctly". The patient did complain of "abdominal pain" and received "an analgesic" (name unknown). The device was removed and replaced with that of another brand. There were no photographs submitted depicting the reported complaint issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007966929-2020-00008 |
| MDR Report Key | 9740650 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-21 |
| Date of Event | 2020-02-11 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2020-02-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JEANETTE JOHNSON |
| Manufacturer Street | 7900 TRIAD CENTER DRIVE SUITE 400 |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 3365424681 |
| Manufacturer G1 | UNOMEDICAL ZAVODSKAYA STREET 50 |
| Manufacturer Street | FE UNOMEDICAL LTD MINSK REGION |
| Manufacturer City | MINSKAYA VOBLASTS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TBD |
| Generic Name | URINE FLOW OR VOLUME MEASURING SYSTEM |
| Product Code | FFG |
| Date Received | 2020-02-21 |
| Model Number | 158101010190 |
| Lot Number | 325388 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNOMEDICAL ZAVODSKAYA STREET 50 |
| Manufacturer Address | FE UNOMEDICAL LTD MINSK REGION MINSKAYA VOBLASTS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-21 |