MAUDE Adverse Event Report: PROXIMATE CONCEPTS LLC INPLANT FUNNEL

Model Number IN-001

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 05/22/2020

Event Type  Injury  

Manufacturer Narrative

This report is a response to medwatch report mw5095094.Proximate concepts performed a manufacturing record evaluation (mre) on the lot of inplant funnels provided in the original medwatch report.The mre concluded that all inplant funnels in lot 040220 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).

Event Description

On 06/17/2020 a surgeon submitted a voluntary report to the fda (mw5095094) regarding an adverse event that occurred 11 days post-surgery.The date of surgery was (b)(6) 2020.According to the surgeon, a high fever (>101) was developed 11 days post-surgery.2 days later, the patient's left incision developed a pinhole incision that began to drain fluid.The report states that the patient had drainage from their incisions.The surgeon returned the patient to the operating room for a washout & implant replacement.The surgeon stated that both pockets had significant inflammation.

• Brand Name: INPLANT FUNNEL
• Type of Device: INPLANT FUNNEL
• Manufacturer (Section D): PROXIMATE CONCEPTS LLC; 6 pearl court; suite h; allendale NJ 07401
• Manufacturer (Section G): PROXIMATE CONCEPTS LLC; 6 pearl court; suite h; allendale NJ 07401
• Manufacturer Contact: salvatore romano ; 6 pearl court; suite h; allendale, NJ 07401 ; 2019138833
• MDR Report Key: 11793637
• MDR Text Key: 249657815
• Report Number: 3013980229-2021-70012
• Device Sequence Number: 1
• Product Code: KDD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2021
• Device Model Number: IN-001
• Device Lot Number: 040220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25 YR