MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-03 for CURE CATHETER M12 manufactured by Cure Medical Llc.
[188138887]
User's technique may have caused or contributed to the adverse event. User reported he was not cleaning the insertion area before insertion. In addition, he reported he was inserting the catheter into a lubricant tube prior to insertion and then reusing the same lubricant tube. He was sent an instruction guide and encouraged to discuss technique with his doctor.
Patient Sequence No: 1, Text Type: N, H10
[188138888]
Intermittent catheter patient (user) reported experiencing a recurrent urinary tract infection (uti). He was prescribed three rounds of antibiotics which at the time of the last communication had been unsuccessful at totally clearing the infection. No device defect or malfunction was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005471919-2020-00008 |
| MDR Report Key | 9781577 |
| Report Source | CONSUMER |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date of Event | 2019-11-30 |
| Date Mfgr Received | 2020-02-04 |
| Device Manufacturer Date | 2019-07-15 |
| Date Added to Maude | 2020-03-03 |
| 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 CATHETER |
| Generic Name | URINARY CATHETER |
| Product Code | EZD |
| Date Received | 2020-03-03 |
| Model Number | M12 |
| Catalog Number | M12 |
| Lot Number | 190715-3 |
| 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 | 2020-03-03 |