MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-03-02 for CURE MEDICAL CATHETER INSERTION KIT K1 manufactured by Cure Medical Llc.
[137680723]
The user's technique was reviewed and it was found that he was handling an alcohol prep pad (manufactured by (b)(4)) that is not part of the sterile insertion kit. The user was using the bzk swab supplied with the kit and the alcohol prep pad to wipe down the gloves. The recommended technique does not call for using a separate alcohol prep pad. The bzk swab supplied in the sterile insertion kit is meant to be used to clean the urethral opening and not the gloves. It is unclear why the user was using the alternate technique and he was advised to discuss his catheterization technique with his doctor as it appears to deviate from accepted clinical practice. Handling of the alcohol prep pad (packaging is not sterile) during the insertion process may lead to contamination of the gloves which are later used to insert the catheter. This report is made for the insertion kit and a separate report is made for the catheter since it cannot be determined the extent to which either device may have caused or contributed to the adverse event.
Patient Sequence No: 1, Text Type: N, H10
[137680724]
Routine intermittent catheter patient (user) acquired a uti while concurrently using both a cure medical brand intermittent catheter and catheter insertion kit (gloves, bzk wipe, collection bag, underpad, lubricating jelly). No specific problems were reported with the catheter or insertion kit but the user stated he had difficulty inserting the catheter. The user also reported he was not following the recommended technique which may introduce contamination that could cause or contribute to an infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005471919-2019-00016 |
| MDR Report Key | 8384561 |
| Report Source | CONSUMER |
| Date Received | 2019-03-02 |
| Date of Report | 2019-03-01 |
| Date of Event | 2018-12-31 |
| Date Mfgr Received | 2019-01-31 |
| Device Manufacturer Date | 2018-03-01 |
| Date Added to Maude | 2019-03-02 |
| 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 CARE TRAY |
| Product Code | OHR |
| Date Received | 2019-03-02 |
| Model Number | K1 |
| Catalog Number | K1 |
| Lot Number | 17B15702 |
| 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 | 2019-03-02 |