MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-27 for SELECT SILICONE FOLEY CATHETER URO170816S manufactured by Medline Industries, Inc..
[185710836]
A 16 french silicone f/c was placed in a female pt prepping for nephrectomy. The balloon ruptured and slid out of pt. No injury to pt. Placed another catheter without difficulty. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093962 |
| MDR Report Key | 9897280 |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-19 |
| Date Added to Maude | 2020-03-30 |
| 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 | RISK MANAGER |
| 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 | SELECT SILICONE FOLEY CATHETER |
| Generic Name | CATHETER CARE TRAY |
| Product Code | OHR |
| Date Received | 2020-03-27 |
| Catalog Number | URO170816S |
| Lot Number | 20ABJ819 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |