MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-03-25 for UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER 25045051 manufactured by Unomedical Ltd.
[41214556]
Postal code: (b)(6), phone number: (b)(6). Based on the available information, this event is deemed a reportable malfunction. No patient harm was reported for this complaint. No lot number or product evaluation sample is available, a detailed investigation or batch review cannot be conducted. Therefore, this evaluation will be closed and will be monitored through our post market product monitoring review process. Should additional information become available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[41214557]
Complaint received from a healthcare professional reporting a physical integrity issue with the device after a "few days" of patient use. Reporter stated "the middle of the collection chamber is broken during use, and thereby the collecting chamber can be disassembled and it is thereby leaking. Collection chamber breaking during use. When opened or closed, the chamber may break and come apart. The consequence is that the system is leaking and flowing urine all over the place. " the reporter provided no patient details, but stated the device was changed to a new one. Photos provided by the reporter show the inlet tubing and open/close level have detached from the chamber. The reporter stated that the device is not available for return.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007966929-2016-00012 |
| MDR Report Key | 5526852 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-03-25 |
| Date of Report | 2016-03-01 |
| Date of Event | 2016-02-18 |
| Date Mfgr Received | 2016-03-01 |
| Date Added to Maude | 2016-03-25 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JEANETTE JOHNSON |
| Manufacturer Street | 7900 TRIAD CENTER DRIVE SUITE 400 |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 3365424681 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER |
| Generic Name | URINOMETER, MECHANICAL |
| Product Code | EXR |
| Date Received | 2016-03-25 |
| Model Number | 25045051 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNOMEDICAL LTD |
| Manufacturer Address | ZAVODSKAYA STREET, 50 FANIPOL DZERZHINSK DISTRICT MINSK REGION, MINSKAYA VOBLASTS 222750 BO 222750 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-25 |