MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-02 for FOLEY CATHETER manufactured by Lubri-sil / Bard Medical.
[90933242]
Pt was sitting in chair after having indwelling foley catheter inserted. It had taken out, the balloon still slightly inflated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073085 |
| MDR Report Key | 6995800 |
| Date Received | 2017-11-02 |
| Date of Report | 2017-10-31 |
| Date of Event | 2017-10-26 |
| Date Added to Maude | 2017-11-02 |
| 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 | 3 |
| Brand Name | FOLEY CATHETER |
| Generic Name | UROLOGICAL CATHETER AND ACCESSORIES |
| Product Code | KNY |
| Date Received | 2017-11-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LUBRI-SIL / BARD MEDICAL |
| Manufacturer Address | COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-11-02 |