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

Lot Number 17NB2154

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/19/2017

Event Type  malfunction  

Event Description

The abdominal drape for chs c-section lot # 17nb2154 came in with a blue tape securing each corner of her bag window of the abdominal drape.In two separate cases, the tape dislodged from the drape traveling into the abdominal i cavity as per (b)(6).Reason for use: drape for c sections.

• Brand Name: MEDLINE
• Type of Device: CHS C-SECTION CESAREAN SECTION TRAY PLUS II
• Manufacturer (Section D): MEDLINE
• MDR Report Key: 6740075
• MDR Text Key: 81045103
• Report Number: MW5071215
• 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: 06/20/2017

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 Lot Number: 17NB2154
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/21/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1