MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-07-23 for SILICONE FOLEY CATHETER manufactured by Medline.
[17993673]
Upon placement and inflation, the y balloon site disassembled, leaving balloon y port without function. Diagnosis or reason for use: labor and delivery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5037446 |
| MDR Report Key | 3961177 |
| Date Received | 2014-07-23 |
| Date of Report | 2014-07-22 |
| Date of Event | 2014-07-11 |
| Date Added to Maude | 2014-07-29 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SILICONE FOLEY CATHETER |
| Generic Name | FOLEY CATHETER |
| Product Code | NWR |
| Date Received | 2014-07-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE |
| Manufacturer Address | MUNDELEIN 60060 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-07-23 |