MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-06 for CURE MEDICAL CATHETER INSERTION KIT K1 manufactured by Cure Medical Llc.
[178101967]
Patient (user) reported lubricant was too sticky and difficult to apply to the catheter which made insertion difficult. He feels the poor lubricant contributed to him acquiring a urinary tract infection. He was prescribed an antibiotic and recovered fully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005471919-2020-00003 |
| MDR Report Key | 9678598 |
| Report Source | CONSUMER |
| Date Received | 2020-02-06 |
| Date of Report | 2020-02-06 |
| Date of Event | 2019-11-30 |
| Date Mfgr Received | 2020-01-07 |
| Device Manufacturer Date | 2018-09-30 |
| Date Added to Maude | 2020-02-06 |
| 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 92663 |
| Manufacturer Country | US |
| Manufacturer Postal | 92663 |
| Manufacturer Phone | 8005701778 |
| Manufacturer G1 | SHAOXING FUQING HEALTH PRODUCTS CO., LTD. |
| Manufacturer Street | NO. 599 WUXIE ROAD SHAOXING HIGH-TECH INDUSTRIAL |
| 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 MEDICAL CATHETER INSERTION KIT |
| Generic Name | CATHETER INSERTION KIT |
| Product Code | OHR |
| Date Received | 2020-02-06 |
| Model Number | K1 |
| Catalog Number | K1 |
| Lot Number | 18301901 |
| 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 92663 US 92663 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-06 |