MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC.; LABOR AND DELIVERY KIT

Model Number DYNJ52236D

Device Problem Contamination (1120)

Patient Problem Insufficient Information (4580)

Event Date 07/15/2021

Event Type  malfunction  

Event Description

Hair was found in the pack when it was opened.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: LABOR AND DELIVERY KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; 1 medline place; mundelein IL 60060
• MDR Report Key: 12614578
• MDR Text Key: 275916653
• Report Number: 12614578
• Device Sequence Number: 1
• Product Code: MLS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DYNJ52236D
• Device Catalogue Number: DYNJ52236D
• Device Lot Number: 21FMC109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/06/2021
• Date Report to Manufacturer: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27010 DA