MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - SPT PAD VAGINAL DELIVERY PACK; LABOR AND DELIVERY KIT

Catalog Number DYNJ50308C

Device Problem Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 03/08/2022

Event Type  malfunction  

Event Description

Raytec only had 19 raytec 4x4's, instead of 20.Fda safety report id # (b)(4).

• Brand Name: PAD VAGINAL DELIVERY PACK
• Type of Device: LABOR AND DELIVERY KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - SPT; northfield IL 60093
• MDR Report Key: 13734055
• MDR Text Key: 287248787
• Report Number: MW5108027
• Device Sequence Number: 1
• Product Code: MLS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ50308C
• Device Lot Number: 21JBV699
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1