MAUDE Adverse Event Report: PROXIMATE CONCEPTS, LLC INPLANT FUNNEL; KIT, SURGICAL INSTRUMENT, DISPOSABLE

Lot Number 031921

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/23/1991

Event Type  No Answer Provided  

Event Description

Patient had breast implants placed with inplant funnel.Approximately 2 weeks later, the patient developed drainage requiring implant removal on the left side.Fda safety report id# (b)(4).

• Brand Name: INPLANT FUNNEL
• Type of Device: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Manufacturer (Section D): PROXIMATE CONCEPTS, LLC; fort lee NJ 07024
• MDR Report Key: 10224158
• MDR Text Key: 197622538
• Report Number: MW5095344
• 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: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 031921
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 66