MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-08-01 for C8323, XXS ALEXIS WND PROT/RET SHRT 5/BX 101432601 manufactured by Applied Medical Resources.
[115778864]
No product is being returned for evaluation and no lot # has been provided to manufacturer. A final report will be sent once the results have been analyzed.
Patient Sequence No: 1, Text Type: N, H10
[115778865]
Procedure performed: "respiratory surgery for lung cancer. " "possibility, that fragment of wound sheath remained in the patient`s body. Due it had a contact with hook shaped cautery knife while operation. We would like to know what would be the possible reaction could happen to the patient. Please kindly advice if it already happened before and we request to have the result report for the same case. " additional information was received via email on 06jul2018 from [distributor]: date of event: "(b)(6) 2018. " procedure being performed: "respiratory surgery for lung cancer. " lot#: "n/a due the operation staff already disposed the package. And we cannot trace from sales record because we supplied a two lot# at the same time. " patient status: "recovering without any problem. " was there any intervention: "after finding out that electron cautery knife had a contact with sheath, and a possibility that fragment of sheath remained inside patient`s body, surgeon clean the cavity and found the fragment. " was the device removed and replaced: "they removed and place a new wound retractor. " reason the device is not available to be returned: "a possibility of infection. " type of intervention: "after finding out that electron cautery knife had a contact with sheath, and a possibility that fragment of sheath remained inside patient`s body, surgeon clean the cavity and found the fragment. They removed and place a new wound retractor. " patient status: "recovering without any problem. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2018-00256 |
| MDR Report Key | 7739802 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-08-01 |
| Date of Report | 2018-09-10 |
| Date of Event | 2018-07-03 |
| Date Mfgr Received | 2018-07-05 |
| Date Added to Maude | 2018-08-01 |
| 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 | C8323, XXS ALEXIS WND PROT/RET SHRT 5/BX |
| Generic Name | KGW |
| Product Code | KGW |
| Date Received | 2018-08-01 |
| Model Number | C8323 |
| Catalog Number | 101432601 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-08-01 |