MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2017-07-10 for URINE METER 158100510190 manufactured by .
[79653869]
(b)(6). Based on the available information, this event is deemed a product malfunction. The device was not used. Additional details have been requested but not provided to date. Should additional information become available, a follow up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[79653870]
Complaint received from distributor reporting, "due to transportation problems, resulting in nine products damaged, after communication with the agents, the final replacement of nine products. Did not cause harm to patients, no equipment combined use. " it was further reported that the damage was to the primary package of the product. No further information has been provided, nor any pictures.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007966929-2017-00034 |
| MDR Report Key | 6699856 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2017-07-10 |
| Date of Event | 2016-11-19 |
| Date Mfgr Received | 2017-09-01 |
| Date Added to Maude | 2017-07-10 |
| 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 | URINE FLOW OR VOLUME MEASURING SYSTEM |
| Product Code | FFG |
| Date Received | 2017-07-10 |
| Model Number | 158100510190 |
| Lot Number | 488936 |
| Device Expiration Date | 2018-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-10 |