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

Model Number	6530-15
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	12/22/2017
Type of Reportable Event	Malfunction
Event or Problem Description
No adverse event reported.This lot of healing collars was not sterilized.

• Brand Name: INTERACTIVE® HEALING COLLAR
• Common Device Name: HEALING COLLAR
• Manufacturer (Section D): IMPLANT DIRECT LLC; 3050 e hillcrest dr.; thousand oaks CA 91362
• MDR Report Key: 7173976
• Report Number: 3001617766-2018-00002
• Device Sequence Number: 19061928
• Product Code: NHA
• UDI-Device Identifier: 10841307109853
• UDI-Public: 10841307109853
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall,Notification
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Other
• Device Model Number: 6530-15
• Device Catalogue Number: 6530-15
• Device Lot Number: 104203
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2017
• Initial Report FDA Received Date: 01/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention