MAUDE Adverse Event Report: MEDIVATORS MEDIVATORS; ENDO CARRY-ON PROCEDURE KIT

Model Number REF# 102875

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Information (3190)

Event Date 08/18/2017

Event Type  malfunction  

Event Description

A live bat was in endopack upon opening, not used on pt.Sales rep notified, and picked up package that was contaminated.

• Brand Name: MEDIVATORS
• Type of Device: ENDO CARRY-ON PROCEDURE KIT
• Manufacturer (Section D): MEDIVATORS; 3150 pollok dr; conroe TX 77300
• MDR Report Key: 6812655
• MDR Text Key: 83507779
• Report Number: MW5071742
• Device Sequence Number: 1
• Product Code: FRG
• UDI-Device Identifier: 00677964000003
• UDI-Public: (01)00677964000003(17)19040(30)1(10)871393
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2019
• Device Model Number: REF# 102875
• Device Lot Number: 87/393/P/33
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1