MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-11-25 for * manufactured by Medline Industries.
[20660404]
8 french foley catheter in place, but not draining. A bladder scan showed full bladder; unable to deflate balloon to reposition. After much difficulty, balloon deflated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3500944 |
| MDR Report Key | 3500944 |
| Date Received | 2013-11-25 |
| Date of Report | 2013-11-25 |
| Date of Event | 2013-11-19 |
| Report Date | 2013-11-25 |
| Date Reported to FDA | 2013-11-25 |
| Date Reported to Mfgr | 2013-12-05 |
| Date Added to Maude | 2013-12-05 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | FOLEY CATHETER |
| Product Code | NWR |
| Date Received | 2013-11-25 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES |
| Manufacturer Address | ONE MEDLINE PL MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-25 |