MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2016-09-15 for ULTRATHANE PERCUTANEOUS PIGTAIL NEPHROSTOMY SET N/A UPPN-080008-CRD manufactured by Cook Inc.
[54766901]
(b)(4). The event is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
[54766902]
A male patient was reportedly having nephrostomy catheter replacements approximately every 3 weeks, on (b)(6) 2016 the catheter was replaced at the hospital. The patient left the hospital after receiving drip infusion for an unknown reason, once home he discovered the catheter was leaking urine. The hospital noted a loose connector was causing the leakage but they were unable to tightened the connection. The patient returned to the hospital but a urological physician was unavailable, he was sent to a nearby hospital where the catheter was replaced. Reportedly the patient developed a fever from pyelonephritis after placement of the new catheter, it is unknown what caused the infection or if it was related to urine leakage and /or catheter replacement. The patient did not experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
[63741293]
(b)(4). Product has not been received and the investigation is ongoing. A follow up report will be sent upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[63741294]
A male patient was reportedly having nephrostomy catheter replacements approximately every 3 weeks, on (b)(6) 2016 the catheter was replaced at the hospital. The patient left the hospital after receiving drip infusion for an unknown reason, once home he discovered the catheter was leaking urine. The hospital noted a loose connector was causing the leakage but they were unable to tightened the connection. The patient returned to the hospital but a urological physician was unavailable, he was sent to a nearby hospital where the catheter was replaced. Reportedly the patient developed a fever from pyelonephritis after placement of the new catheter, it is unknown what caused the infection or if it was related to urine leakage and /or catheter replacement. The patient did not experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
[117886496]
(b)(4). A review of the complaint history, manufacturing instructions, and quality control was conducted during the investigation. The complaint device was not returned; therefore no physical examination could be performed. The lot number of the device is not known; accordingly a review of the device history record could not be conducted. Based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined. Per the quality engineering risk assessment, no further action is warranted. Monitoring will continue to be performed for similar complaints.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2016-00975 |
| MDR Report Key | 5952181 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2016-09-15 |
| Date of Report | 2017-07-13 |
| Date of Event | 2016-08-19 |
| Date Mfgr Received | 2017-06-28 |
| Date Added to Maude | 2016-09-15 |
| 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 | ULTRATHANE PERCUTANEOUS PIGTAIL NEPHROSTOMY SET |
| Generic Name | KOB CATHETER, SUPRAPUBIC (AND ACCESSORIES) |
| Product Code | KOB |
| Date Received | 2016-09-15 |
| Model Number | N/A |
| Catalog Number | UPPN-080008-CRD |
| 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 | 2016-09-15 |