MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-11-08 for C8301, S ALEXIS WND PROT/RET 5/BX 101355701 manufactured by Applied Medical Resources.
[92538819]
The event unit was not returned to applied medical for evaluation. In the absence of the subject device, it is difficult to determine the root cause of the event. Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.
Patient Sequence No: 1, Text Type: N, H10
[92538820]
Procedure performed - video assisted thoracic surgery - lobectomy "removing from patient alexis ripped in half no harm to patient. " additional information received via email at october 10, 2017 from material management at (b)(6) hospital. The device is not available for return as the device is with risk management department and will be secured at the hospital. The location of the rip is in the center of the sheath. " the rings are intact". All material was retrieved. Patient status - "no harm to patient. " type of intervention - na.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2017-02104 |
| MDR Report Key | 7010586 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-11-08 |
| Date of Report | 2017-11-08 |
| Date of Event | 2017-10-05 |
| Date Mfgr Received | 2017-10-09 |
| Device Manufacturer Date | 2017-07-01 |
| Date Added to Maude | 2017-11-08 |
| 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 | WENDY KOBAYASHI |
| Manufacturer Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal | 92688 |
| Manufacturer Phone | 9497138059 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | C8301, S ALEXIS WND PROT/RET 5/BX |
| Generic Name | KGW |
| Product Code | KGW |
| Date Received | 2017-11-08 |
| Model Number | C8301 |
| Catalog Number | 101355701 |
| Lot Number | 1300056 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL RESOURCES |
| Manufacturer Address | 22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US 92688 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-08 |