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 2020-01-21 for WAYNE PNEUMOTHORAX SET C-UTPT-1400-WAYNE-112497-IMH manufactured by Cook Inc.
[177372490]
(b)(6). Occupation: unknown: pma/510(k) #: exempt. 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
[177372491]
It was reported that during icc insertion, the guide wire of a wayne pneumothorax set split, making it impossible to pass the dilator. Consequently, a new set had to be prepared. The patient was reported to have been sedated during the procedure. Additional information regarding the device and event has been requested but is unavailable at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2020-00177 |
| MDR Report Key | 9611867 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-21 |
| Date of Report | 2020-03-10 |
| Date of Event | 2019-12-25 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-05-03 |
| Date Added to Maude | 2020-01-21 |
| 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 | WAYNE PNEUMOTHORAX SET |
| Generic Name | JOL CATHETER AND TIP, SUCTION |
| Product Code | JOL |
| Date Received | 2020-01-21 |
| Model Number | NA |
| Catalog Number | C-UTPT-1400-WAYNE-112497-IMH |
| Lot Number | 9681593 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-01-21 |