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 2017-08-14 for C8402, M ALEXIS O WND PROT/RET 5/BX 3 manufactured by Applied Medical Resources.
[82776460]
The event device is anticipated to return. A follow-up report will be provided upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[82776461]
Procedure performed: thoracotomy. Event description: sheath tore. It was reported that the facility is not sure how the tear occurred. No metal retractors were used over the device. The surgeon has used the alexis for a thoracotomy procedure previously without incident. No patient injury. No additional information regarding the location of the tear nor the timing of the tear during the procedure. No additional information regarding how the tear occurred or how the procedure was completed. Type of intervention: na. Patient status - no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2017-01932 |
| MDR Report Key | 6793279 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-08-14 |
| Date of Report | 2017-10-03 |
| Date of Event | 2017-07-26 |
| Date Mfgr Received | 2017-07-26 |
| Device Manufacturer Date | 2016-10-01 |
| Date Added to Maude | 2017-08-14 |
| 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 | C8402, M ALEXIS O WND PROT/RET 5/BX |
| Generic Name | KGW |
| Product Code | KGW |
| Date Received | 2017-08-14 |
| Returned To Mfg | 2017-08-08 |
| Model Number | 3 |
| Catalog Number | 3 |
| Lot Number | 1280728 |
| Device Expiration Date | 2019-10-20 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-08-14 |