MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-11-01 for COONS INTERVENTIONAL WIRE GUIDE N/A THSF-35-145-COONS manufactured by Cook Inc.
[164889683]
Occupation: strategic sourcing contracting manager. Initial reporter also sent report to fda: unknown. Pma/510(k) #: pre-amendment. (b)(4). A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[164889684]
It was reported an unknown patient required use of a coons interventional wire guide for a left ureteroscopy stone manipulation and stent procedure. At a later date, the physician noticed a "piece of the fractured ureteral wire" in the patient via xray. The fractured piece was retrieved with two additional surgeries. No other adverse effects were reported for this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-02753 |
| MDR Report Key | 9267517 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-11-01 |
| Date of Report | 2019-11-01 |
| Date of Event | 2019-08-07 |
| Date Mfgr Received | 2019-10-17 |
| Date Added to Maude | 2019-11-01 |
| 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 |
| 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 | COONS INTERVENTIONAL WIRE GUIDE |
| Generic Name | DQX WIRE, GUIDE, CATHETER |
| Product Code | DXQ |
| Date Received | 2019-11-01 |
| Model Number | N/A |
| Catalog Number | THSF-35-145-COONS |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-11-01 |