MAUDE Adverse Event Report: MEDLINE INDUSTRIES MUNDELEIN MEDLINE C-SECTION PACK; CESAREAN SECTION TRAY

Model Number DYNJ61561

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/24/2019

Event Type  Injury  

Event Description

Two tears in c-section pack blue drape, approximately 1 inch and 1.5 inch in length.

• Brand Name: MEDLINE C-SECTION PACK
• Type of Device: CESAREAN SECTION TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES MUNDELEIN
• MDR Report Key: 8944506
• MDR Text Key: 156087217
• Report Number: MW5089412
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 08/26/2019

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 Model Number: DYNJ61561
• Device Catalogue Number: DYNJ61561
• Device Lot Number: 19RBA186
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2019
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR