MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-11-29 for SILICONE MALECOT CATHETER 083814 manufactured by Cook Inc.
[93189719]
(b)(4). The event is currently under investigation. A follow up report will be submitted upon receipt of additional information or completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[93189720]
The user facility reported during a hutch diverticulectomy and right ureteral reimplant procedure, the distal portion of the catheter and cage broke off. The patient was returned to the operating room to remove the retained portion of the catheter located in the retroperitoneum. No adverse effects or consequences were reported to the patient due to this occurrence. Additional information has been requested from the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2017-04330 |
| MDR Report Key | 7066773 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-11-29 |
| Date of Report | 2018-03-01 |
| Date of Event | 2017-10-30 |
| Date Mfgr Received | 2018-02-02 |
| Date Added to Maude | 2017-11-29 |
| 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 | SILICONE MALECOT CATHETER |
| Generic Name | KOB CATHETER, SUPRAPUBIC (AND ACCESSORIES) |
| Product Code | KOB |
| Date Received | 2017-11-29 |
| Catalog Number | 083814 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Required No Informationntervention | 2017-11-29 |