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 2020-01-07 for URINE METER 25033183 manufactured by Unomedical Zavodskaya Street 50.
[175020268]
(b)(6). Affiliation: (b)(6) hospital. Based on the available information, this event is deemed to be a reportable malfunction. No samples were received. A photo was received and evaluated. Hair was observed in the photo. The defect was confirmed. A batch record review was performed. The batch record review identified a discrepancy which was investigated via a non-conformance: "hair inside product individual package?. A root cause investigation was performed. On the basis of available information, the following potential causes for the issue? Hair inside of primary pack? Were determined: noncompliance with the rules of movements and stay in classified rooms by operators during the manufacturing process. Cap does not provide full cover of hairs. No additional investigation or actions were taken. The trend will be monitored. This issue will be monitored through the post market product monitoring review process. 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
[175020269]
It was reported a human hair was found inside the packaging. Photos depicting the reported complaint issue were provided by the complainant. The product was not used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007966929-2020-00001 |
| MDR Report Key | 9559727 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-07 |
| Date Mfgr Received | 2019-09-18 |
| Date Added to Maude | 2020-01-07 |
| 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 | URINE METER |
| Generic Name | DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE |
| Product Code | FFG |
| Date Received | 2020-01-07 |
| Model Number | 25033183 |
| Lot Number | 327581 |
| 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 | 2020-01-07 |