MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-12 for FORTUNE MEDICAL SUPRAPUBIC TUBE 16 FR WITH 10 ML BALLOON manufactured by Fortune Medical.
[45373133]
Suprapubic catheter placed by urology. Two days later, sp catheter stopped draining, found to have perforated foley balloon, requiring another operating room for exchange. Malfunctioning catheter was retrieved and saved. Nurse had been irrigating for hematuria without difficulty and then noted only 30 cc could be instilled. Also noted leaking around insertion site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5062268 |
| MDR Report Key | 5658700 |
| Date Received | 2016-05-12 |
| Date of Report | 2016-05-12 |
| Date of Event | 2016-05-07 |
| Date Added to Maude | 2016-05-17 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FORTUNE MEDICAL SUPRAPUBIC TUBE |
| Generic Name | SUPRAPUBIC TUBE |
| Product Code | KOB |
| Date Received | 2016-05-12 |
| Model Number | 16 FR WITH 10 ML BALLOON |
| Lot Number | A3-012145 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FORTUNE MEDICAL |
| Manufacturer Address | NEW TAIPEI CITY, DANSHUEI DIST 251 TW 251 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-05-12 |