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 2017-11-02 for C8402, M ALEXIS O WND PROT/RET 5/BX 101356201 manufactured by Applied Medical Resources.
[90937212]
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
[90937213]
Procedure performed: "hals procedure". Event description: "surgeon was doing a hals procedure with gelport and after the procedure was over the inner green ring was left inside of the patient which was not discovered until 8 years later. " additional information was received via telephone from territory manager on friday (b)(6) 2017: " i have no information on this situation. I don't know the lot # or the institution of where it happened. It happened somewhere in nashville, tn. I don't know when this event occurred. I really have no information at all" type of intervention: unknown. Patient status: unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2017-02100 |
| MDR Report Key | 6998226 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-11-02 |
| Date of Report | 2017-11-22 |
| Date Mfgr Received | 2017-10-05 |
| Date Added to Maude | 2017-11-02 |
| 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 | 2017-11-02 |
| Model Number | C8402 |
| Catalog Number | 101356201 |
| 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 | 1. Other | 2017-11-02 |