• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

IMPLANT DIRECT LLC INTERACTIVE® HEALING COLLAR Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7173976
MDR Text Key97063829
Report Number3001617766-2018-00002
Device Sequence Number1
Product Code NHA
UDI-Device Identifier10841307109853
UDI-Public10841307109853
Combination Product (y/n)N
PMA/PMN Number
K130572
Number of Events Reported1
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 Number6530-15
Device Catalogue Number6530-15
Device Lot Number104203
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/22/2017
Initial Date FDA Received01/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/25/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-