MAUDE Adverse Event Report: MEDLINE CHS C-SECTION PLUS II

Catalog Number DYNJCH0B03

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

Patient Problem No Information (3190)

Event Date 06/27/2018

Event Type  malfunction  

Event Description

Small piece of wood found on sterile lap within a cesarean section pack.Package discarded.Picture of foreign object taken.

• Brand Name: CHS C-SECTION PLUS II
• Type of Device: CHS C-SECTION PLUS II
• Manufacturer (Section D): MEDLINE
• MDR Report Key: 7685078
• MDR Text Key: 114016748
• Report Number: MW5078349
• Device Sequence Number: 1
• Product Code: OHM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/28/2018

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: DYNJCH0B03
• Device Lot Number: 17KB8209
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/12/2018
• 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