MAUDE Adverse Event Report: IMPLANT DIRECT LLC INTERACTIVE® HEALING COLLAR

Model Number 6530-15

Device Problem Delivered as Unsterile Product (1421)

Patient Problem Not Applicable (3189)

Event Date 12/22/2017

Event Type  malfunction  

Event Description

No adverse event reported.This lot of healing collars was not sterilized.

• Brand Name: INTERACTIVE® HEALING COLLAR
• Type of Device: HEALING COLLAR
• Manufacturer (Section D): IMPLANT DIRECT LLC; 3050 e hillcrest dr.; thousand oaks CA 91362
• Manufacturer (Section G): IMPLANT DIRECT LLC; 3050 e hillcrest dr.; thousand oaks CA 91362
• Manufacturer Contact: evan garner ; 3050 e hillcrest dr.; thousand oaks, CA 91362 ; 8184443300
• MDR Report Key: 7173976
• MDR Text Key: 97063829
• Report Number: 3001617766-2018-00002
• Device Sequence Number: 1
• Product Code: NHA
• UDI-Device Identifier: 10841307109853
• UDI-Public: 10841307109853
• Combination Product (y/n): N
• PMA/PMN Number: K130572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 6530-15
• Device Catalogue Number: 6530-15
• Device Lot Number: 104203
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/22/2017
• Initial Date FDA Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention