MAUDE Adverse Event Report: AVID PACK, TOTAL JOINT ORTHOPACK (CUSTOM PACK); ORTHOPEDIC TRAY

Catalog Number MCHC006-09

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/06/2017

Event Type  malfunction  

Event Description

There was a hair found inside the spit drape that comes in the avid total joint pack.Diagnosis or reason for use: surgery.

• Brand Name: PACK, TOTAL JOINT ORTHOPACK (CUSTOM PACK)
• Type of Device: ORTHOPEDIC TRAY
• Manufacturer (Section D): AVID
• MDR Report Key: 6629502
• MDR Text Key: 77318369
• Report Number: MW5070256
• Device Sequence Number: 1
• Product Code: OJH
• 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: 06/07/2017

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: Health Professional
• Device Catalogue Number: MCHC006-09
• Device Lot Number: 1218859
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/07/2017
• 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
• Patient Age: 63 YR