MAUDE Adverse Event Report: REMEL THERMO FISHER SCIENTIFIC REMEL SABOURAUD DEXTROSE CONTACT PLATE

Catalog Number R111105

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

Patient Problem No Information (3190)

Event Date 08/07/2017

Event Type  malfunction  

Event Description

Technician opened box of remel sab dex contact plates (product #r111105, lot #177380, exp #09/21/2017) to find one contaminated with profuse black growth.Reported to thermo fisher scientific.

• Brand Name: REMEL SABOURAUD DEXTROSE CONTACT PLATE
• Type of Device: SABOURAUD DEXTROSE CONTACT PLATE
• Manufacturer (Section D): REMEL THERMO FISHER SCIENTIFIC; lenexa KS 66215
• MDR Report Key: 6776817
• MDR Text Key: 82452195
• Report Number: MW5071455
• Device Sequence Number: 1
• Product Code: JSG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 08/07/2017

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 Expiration Date: 09/21/2017
• Device Catalogue Number: R111105
• Device Lot Number: 177380
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/07/2017
• 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