MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-20 for THAL-QUICK G06786 manufactured by Cook, Inc..
[57931682]
Patient Sequence No: 1, Text Type: N, H10
[57931683]
Guide wire not removed after chest tube placement. Tag that says "remove dilator after chest tube insertion" is not very noticeable or understandable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6043236 |
| MDR Report Key | 6043236 |
| Date Received | 2016-10-20 |
| Date of Report | 2016-10-07 |
| Date of Event | 2016-07-14 |
| Report Date | 2016-10-07 |
| Date Reported to FDA | 2016-10-07 |
| Date Reported to Mfgr | 2016-10-07 |
| Date Added to Maude | 2016-10-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THAL-QUICK |
| Generic Name | CATHETER, IRRIGATION |
| Product Code | PAD |
| Date Received | 2016-10-20 |
| Model Number | G06786 |
| Catalog Number | G06786 |
| Lot Number | 6854808 |
| ID Number | C-TQTS-800 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| 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. Hospitalization; 2. Required No Informationntervention | 2016-10-20 |