MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2017-11-17 for URINE METER 25045182 manufactured by .
[93133172]
(b)(6). Based on the available information, this event is deemed to be a reportable malfunction. No additional information has been received to date. Should additional information become available a follow-up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[93133173]
The distributor reported there was hair in the primary sterile bag. A photograph was provided depicting the reported complaint issue. It was further reported that the device was not used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007966929-2017-00061 |
| MDR Report Key | 7041162 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2017-11-17 |
| Date Mfgr Received | 2018-01-23 |
| Date Added to Maude | 2017-11-17 |
| 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 |
| 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 | 2017-11-17 |
| Returned To Mfg | 2017-11-03 |
| Model Number | 25045182 |
| Lot Number | 307529 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-17 |