MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-07-22 for PERCUTANEOUS PIGTAIL NEPHROSTOMY ACCESSORY SET 080010 manufactured by Cook Urological Inc.
[4816375]
Dilator broke in half while dilating. Half of the dilator was left in the patient. The device was removed from the patient successfully with no harm or need to additional procedures.
Patient Sequence No: 1, Text Type: D, B5
[12323635]
(b)(4). Event evaluation: still under investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2014-00313 |
| MDR Report Key | 3980948 |
| Report Source | 07 |
| Date Received | 2014-07-22 |
| Date of Report | 2014-06-26 |
| Date of Event | 2014-06-26 |
| Date Facility Aware | 2014-06-26 |
| Report Date | 2014-06-26 |
| Date Mfgr Received | 2014-06-27 |
| Device Manufacturer Date | 2013-10-17 |
| Date Added to Maude | 2014-08-06 |
| 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 | 0 |
| 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 | PERCUTANEOUS PIGTAIL NEPHROSTOMY ACCESSORY SET |
| Generic Name | KOB CATHETER, SUPRAPUBIC ( AND ACCESSORIES) |
| Product Code | KOB |
| Date Received | 2014-07-22 |
| Model Number | NA |
| Catalog Number | 080010 |
| Lot Number | U2413160 |
| ID Number | NA |
| Device Expiration Date | 2016-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 8 MO |
| 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 | 1. Required No Informationntervention | 2014-07-22 |