MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-05-23 for UNOMETER SAFETI+HK 150CMTBNG LRL 1X10INT 413455 manufactured by Unomedical Zavodskaya Street 50.
[146238464]
(b)(6). 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. Fda registration number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[146238465]
It was reported that "the urine is retained in the proximal area proximal to the catheter and can not make its way to the drainage bag. The retention point is the white filter". Additional information was received clarifying the catheter connector is where the "white filter" is located within the product that caused "hinder urine". It is unclear as to how long the product was in use prior to noting the stated issue. Bladder ballooning was performed after the product was removed. No harm was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007966929-2019-00015 |
| MDR Report Key | 8637978 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2019-05-23 |
| Date of Event | 2019-05-03 |
| Date Mfgr Received | 2019-05-03 |
| Date Added to Maude | 2019-05-23 |
| 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 | UNOMETER SAFETI+HK 150CMTBNG LRL 1X10INT |
| Generic Name | DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE |
| Product Code | FFG |
| Date Received | 2019-05-23 |
| Model Number | 413455 |
| Lot Number | 202038 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-05-23 |