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 2019-11-26 for FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET N/A C-PPD-850-IMH manufactured by Cook Inc.
[177163366]
(b)(6). Occupation: interne pharmacie. 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
[177163367]
It was reported that during placement of pneumothorax drainage in the pleural space, the wire guide of a fuhrman pleural/pneumopericardial drainage set broke upon retrieval. After the drain placement, the physician removed the wire guide and found the distal extremity to be broken. No harm or adverse effects to the patient have been reported. Additional information regarding the event has been requested but is unavailable at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-02954 |
| MDR Report Key | 9376283 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-11-26 |
| Date of Report | 2019-11-26 |
| Date of Event | 2019-10-28 |
| Date Mfgr Received | 2019-11-12 |
| Date Added to Maude | 2019-11-26 |
| 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 | FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET |
| Generic Name | GBX CATHETER, IRRIGATION |
| Product Code | GBX |
| Date Received | 2019-11-26 |
| Model Number | N/A |
| Catalog Number | C-PPD-850-IMH |
| 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 | 2019-11-26 |