MAUDE Adverse Event Report:; INPLANT FUNNEL

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

Patient Problems Fever (1858); Fluid Discharge (2686)

Event Type  Injury  

Manufacturer Narrative

Customer has indicated that the device will not be returned to proximate concepts for analysis, as the device has been discarded.A manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specifications and procedures.As such, this complaint will be closed.Manufacturer's reference number: (b)(4).

Event Description

Dr.(b)(6) submitted a report to the fda (mw5098741) in regards to an adverse event during his operation.Dr.(b)(6) stated in his report that a (b)(6) female with no prior medical history underwent a breast augmentation surgery, in which an inplant funnel (lot 062320) was used, on (b)(6) 2020.Days after the surgery, the patient reported a fever and began broad-spectrum antibiotics shortly after.She returned to the operating room in 2021 and dr.(b)(6) reported that she experienced drainage of brown murky fluid around both the left and right breast implants.Both implants were removed and the pockets were irrigated and closed.Proximate concepts followed up with dr.(b)(6) in an attempt to gain more information pertaining to the event.Dr.(b)(6) was able to provide the lab tests done on the patient.The culture failed to isolate any aerobic organisms or anaerobes, yielding a negative result.Proximate concepts performed a manufacturing record evaluation (mre), which concluded that all inplant funnel's in lot 062320 were manufactured in accordance with documented specifications and procedures.As a result of proximate concepts' investigation, the cause of the adverse event cannot be traced back to the inplant funnel.As such, this complaint will be closed.Manufacturer's reference number: (b)(4).

• Type of Device: INPLANT FUNNEL
• Manufacturer Contact: 6 pearl court; suite h; allendale, NJ 07401
• MDR Report Key: 11335345
• MDR Text Key: 232150875
• Report Number: 3013980229-2021-70003
• Device Sequence Number: 1
• Product Code: KDD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1