MAUDE Adverse Event Report: MEDOVATIONS INC. WEIGHTRIGHT MERCURY-FREE; BOUGIE, ESOPHAGEAL, AND GASTROINTESTINAL, GASTRO-UROLOGY

Model Number 1208-52

Device Problem Device Expiration Issue (1216)

Patient Problem No Information (3190)

Event Date 09/08/2015

Event Type  malfunction  

Event Description

When the nurse and tech went to the shelf they noticed the bougie tubes had a lot number and date that seemed to be put on the tubes with a marker instead of being stamped on.Hard to tell.Items were expiring and rep told the operating room staff not to use them since they were expiring.

• Brand Name: WEIGHTRIGHT MERCURY-FREE
• Type of Device: BOUGIE, ESOPHAGEAL, AND GASTROINTESTINAL, GASTRO-UROLOGY
• Manufacturer (Section D): MEDOVATIONS INC.; 102 east keefe avenue; milwaukee WI 53212
• Manufacturer Contact: 102 east keefe ave.; milwaukee, WI 53212 ; 265-7620
• MDR Report Key: 5103678
• MDR Text Key: 26738313
• Report Number: 5103678
• Device Sequence Number: 1
• Product Code: FAT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 09/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/01/2015
• Device Model Number: 1208-52
• Device Catalogue Number: 1208-52
• Device Lot Number: 213676
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/18/2015
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1