MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-05-17 for BUSH URETERAL ILLUMINATING CATHETER SET 084120 manufactured by Cook Urological Inc.
[3453496]
A dime size area of redness was noted on the patient's thigh when transferring patient to bed at 1440. At 1630 patient complaint of severe pain. The area had increased in size and was blistered. Area was treated in hospital with topical antibiotic. Patient is now being followed up on by plastic surgeon. No additional patient outcome was provided by the reporter.
Patient Sequence No: 1, Text Type: D, B5
[10711417]
Expiration date: unknown as lot is unknown. Burning and blistering from heat are not labeled in the ifu. The complaint device was not returned, so no physical evaluation could be performed. Also, the customer was unresponsive to repeated attempts to get answers to questions that would aid in the investigation. Based purely on the description of the event, it is most likely that the customer was using a high-energy light source that caused the fitting of the catheter to become hot and resulted in the burn. The instructions for use for the device states: high energy light source such as xenon may cause overheating of the anodized aluminum plug. An appropriate adapter will ensure product safety and functionality. Although the devices are 100% inspected, cook cannot control light source/settings utilized by the customer. The cause of this event was most likely the customer's use of a high-energy light source, which caused the fitting to become hot and resulted in a burn to the patient. We continue to monitor for similar events and have notified the appropriate internal personnel. Due to the product not being returned and low overall risk to patient, no corrective action was initiated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2013-00194 |
| MDR Report Key | 3124043 |
| Report Source | 06 |
| Date Received | 2013-05-17 |
| Date of Report | 2013-04-17 |
| Date of Event | 2013-04-02 |
| Date Facility Aware | 2013-04-02 |
| Report Date | 2013-04-17 |
| Date Mfgr Received | 2013-04-18 |
| Date Added to Maude | 2013-05-23 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | RITA HARDEN, DIRECTOR |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BUSH URETERAL ILLUMINATING CATHETER SET |
| Generic Name | FCS CATHETER, LIGHT, FIBEROPTIC, GLASS, URETERAL |
| Product Code | FCS |
| Date Received | 2013-05-17 |
| Model Number | NA |
| Catalog Number | 084120 |
| Lot Number | UNKNOWN |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK UROLOGICAL INC |
| Manufacturer Address | SPENCER IN 47460 US 47460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-17 |