MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8402, M ALEXIS O WND PROT/RET 5/BX; KGW

Model Number C8402

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.As a result, the complainant's experience could not be confirmed.In the absence of the subject device, it is difficult to determine the root cause of the event.Applied medical has reviewed the details surrounding the event and related product.At this time, applied medical is unable to determine the cause of the reported event.Although the root cause of the reported event could not be confirmed, 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.

• Brand Name: C8402, M ALEXIS O WND PROT/RET 5/BX
• Type of Device: KGW
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: wendy kobayashi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138059
• MDR Report Key: 6998226
• MDR Text Key: 90937212
• Report Number: 2027111-2017-02100
• Device Sequence Number: 1
• Product Code: KGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: C8402
• Device Catalogue Number: 101356201
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other