MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-27 for CURE MALE ULTRA ULTRA M14 manufactured by Cure Medical Llc.
[186744971]
Patient (user) reported he acquired a routine urinary tract infection. He emphasized that it was not due to any defect or malfunction with the catheter. He said an infection now and then is routine for those who catheterize and didn't feel it was caused by the catheter. The patient was prescribed an antibiotic and has fully recovered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005471919-2020-00012 |
| MDR Report Key | 9889704 |
| Report Source | CONSUMER |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-06 |
| Date Mfgr Received | 2020-03-13 |
| Date Added to Maude | 2020-03-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | SCOTT STILES |
| Manufacturer Street | 3471 VIA LIDO, #211 |
| Manufacturer City | NEWPORT BEACH, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 5701778 |
| Manufacturer G1 | INTEGRAL MEDICAL PRODUCTS CO., LTD. |
| Manufacturer Street | NO. 2 DONGZE ROAD HIGH-TECH INDUSTRIAL DEVELOPME |
| Manufacturer City | SHAOXING, ZHEJIANG 312000 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 312000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CURE MALE ULTRA |
| Generic Name | URINARY CATHETER |
| Product Code | KOD |
| Date Received | 2020-03-27 |
| Model Number | ULTRA M14 |
| Catalog Number | ULTRA M14 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CURE MEDICAL LLC |
| Manufacturer Address | 3471 VIA LIDO, #211 NEWPORT BEACH, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-27 |