MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING, LLC SWISH¿ DUO-GRIP¿ HEALING COLLAR

Model Number 9048-13H

Device Problems Nonstandard Device (1420); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 03/09/2017

Event Type  malfunction  

Event Description

The swish duo-grip healing collar part number 9048-13h was miss-packaged and a 9037-13h was packaged instead.

• Brand Name: SWISH¿ DUO-GRIP¿ HEALING COLLAR
• Type of Device: HEALING COLLAR
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING, LLC; 3050 e. hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: leopoldo meza ; 3050 e. hillcrest drive; thousand oaks, CA 91362 ; 8184443300
• MDR Report Key: 6679142
• MDR Text Key: 78908165
• Report Number: 3001617766-2017-00003
• Device Sequence Number: 1
• Product Code: NHA
• UDI-Device Identifier: 10841307115861
• UDI-Public: 10841307115861
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K090234
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9048-13H
• Device Catalogue Number: 9048-13H
• Device Lot Number: 81080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1