MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-06 for FILIFORM DOUBLE PIGTAIL URETERAL STENT SET 133624 manufactured by Cook Inc.
[183350411]
Initial reporter: postal code: postal code: (b)(6). Pma/510k #: pre-amendment. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[183350412]
It was reported, the package for a filiform double pigtail ureteral stent set was opened, and a hair was discovered inside. There was no patient contact. No adverse effects have been reported. Additional information has been requested. At this time, no other information is known. A follow up report will be submitted if additional details are received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2020-00560 |
| MDR Report Key | 9799433 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-02-25 |
| Date Mfgr Received | 2020-03-26 |
| Device Manufacturer Date | 2019-12-05 |
| Date Added to Maude | 2020-03-06 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. JENNIFER CANADA |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC. |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FILIFORM DOUBLE PIGTAIL URETERAL STENT SET |
| Generic Name | FAD STENT, URETERAL |
| Product Code | FAD |
| Date Received | 2020-03-06 |
| Returned To Mfg | 2020-03-19 |
| Catalog Number | 133624 |
| Lot Number | 10193544 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-06 |