MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-06-09 for FILIFORM DOUBLE PIGTAIL URETERAL STENT SET N/A 133724 manufactured by Cook Inc.
[77276008]
(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
[77276009]
The customer reported that the physician was performing an intended cystoscopy procedure to remove previously implanted black silicone stent (gpn unknown). During the cystoscopy, the physician noticed that the black silicone stent was broken into several pieces inside of the patient? S body. The stent had been inside of the patient's body for four months. The physician removed the old stent using graspers. No unintended section of the device remained inside the patient? S body. The patient did not require an additional procedure due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence. Additional information was requested regarding the lot number of the device, however, it was reported that the lot number is not available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2017-01432 |
| MDR Report Key | 6629470 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-06-09 |
| Date of Report | 2017-10-25 |
| Date of Event | 2017-05-12 |
| Date Mfgr Received | 2017-10-10 |
| Date Added to Maude | 2017-06-09 |
| 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 | FILIFORM DOUBLE PIGTAIL URETERAL STENT SET |
| Product Code | EYB |
| Date Received | 2017-06-09 |
| Model Number | N/A |
| Catalog Number | 133724 |
| 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. Required No Informationntervention | 2017-06-09 |