MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2017-07-21 for PERCUTANEOUS PIGTAIL NEPHROSTOMY ACCESSORY SET 080006 manufactured by Cook Inc.
[80693440]
(b)(4). The event is currently under investigation. A supplemental report will be provided upon conclusion.
Patient Sequence No: 1, Text Type: N, H10
[80693441]
It was reported that the patient's catheter and urine were stained with a violet color, so the catheter was exchanged. This is a possible indicator of a urinary tract infection (uti), so the customer has been asked if the patient had an active uti, and whether it began before or after the device was placed. A response has not been received, so this information is still unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2017-01859 |
| MDR Report Key | 6732473 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2017-07-21 |
| Date of Report | 2018-02-20 |
| Date Mfgr Received | 2018-01-25 |
| Date Added to Maude | 2017-07-21 |
| 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 | MR. LARRY POOL |
| 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 | PERCUTANEOUS PIGTAIL NEPHROSTOMY ACCESSORY SET |
| Generic Name | KOB CATHETER, SUPRAPUBIC (AND ACCESSORIES) |
| Product Code | KOB |
| Date Received | 2017-07-21 |
| Catalog Number | 080006 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-07-21 |