MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2018-05-02 for PERCUTANEOUS MALECOT NEPHROSTOMY CATHETER SET 082014-ET manufactured by Cook Inc.
[107188186]
(b)(4). This mdr is being filed after the associated complaint was reviewed under remediation protocol cap008, complaint/mdr retrospective review and remediation and reassessed as reportable. Additional complaint investigation and record remediation was not performed.
Patient Sequence No: 1, Text Type: N, H10
[107188187]
It was reported that the patient returned after about one week as the adaptor of the nephrostomy catheter had come off; there was urine leakage noted. The catheter was replaced with another product with no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-01371 |
| MDR Report Key | 7480934 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2018-05-02 |
| Date of Report | 2018-05-02 |
| Date of Event | 2015-08-29 |
| Date Mfgr Received | 2018-05-02 |
| Date Added to Maude | 2018-05-02 |
| 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 | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8128294891 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERCUTANEOUS MALECOT NEPHROSTOMY CATHETER SET |
| Generic Name | KOB CATHETER, SUPRAPUBIC (AND ACCESSORIES) |
| Product Code | KOB |
| Date Received | 2018-05-02 |
| Catalog Number | 082014-ET |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-05-02 |