MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-09 for MEDLINE TEMPERATURE SENSING CATHETER W/UROMETER BAG,INDWELLING CATHETER TEMP SE DYND110516 manufactured by Medline.
[116961426]
Urometer foley drainage bag began leaking at seam of bottom of bag.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079043 |
| MDR Report Key | 7772632 |
| Date Received | 2018-08-09 |
| Date of Report | 2018-08-08 |
| Date of Event | 2018-07-31 |
| Date Added to Maude | 2018-08-10 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Brand Name | MEDLINE TEMPERATURE SENSING CATHETER W/UROMETER BAG,INDWELLING CATHETER TEMP SE |
| Generic Name | URINARY DRAINAGE COLLECTION KIT FOR INDWELLING CATHETER |
| Product Code | FCN |
| Date Received | 2018-08-09 |
| Catalog Number | DYND110516 |
| Lot Number | NGCR0131 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE |
| Manufacturer Address | MUNDELIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-09 |