IMPLANT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-29 for IMPLANT manufactured by Proximate Concepts Llc.

MAUDE Entry Details

• Report Number: MW5088547
• MDR Report Key: 8843446
• Date Received: 2019-07-29
• Date of Report: 2019-07-29
• Date of Event: 2018-06-08
• Date Added to Maude: 2019-07-30
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• 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
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: IMPLANT
• Generic Name: KIT, SURGICAL, DISPOSABLE
• Product Code: KDD
• Date Received: 2019-07-29
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PROXIMATE CONCEPTS LLC

Device Sequence Number: 2

• Brand Name: IMPLANT
• Generic Name: KIT, SURGICAL, DISPOSABLE
• Product Code: KDD
• Date Received: 2019-07-29
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: PROXIMATE CONCEPTS LLC

Device Sequence Number: 3

• Brand Name: IMPLANT
• Generic Name: KIT, SURGICAL, DISPOSABLE
• Product Code: KDD
• Date Received: 2019-07-29
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: PROXIMATE CONCEPTS LLC

Device Sequence Number: 4

• Brand Name: IMPLANT
• Generic Name: KIT, SURGICAL, DISPOSABLE
• Product Code: KDD
• Date Received: 2019-07-29
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: PROXIMATE CONCEPTS LLC

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2019-07-29