MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - SPT BASIC GYN ROBOTICS DRAPE; LABOR AND DELIVERY KIT

Model Number CMPJ05907

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 04/04/2022

Event Type  malfunction  

Event Description

Medline industries basic gyn robotics drape had a 3 inch slit upon opening.Fda safety report id # (b)(4).

• Brand Name: BASIC GYN ROBOTICS DRAPE
• Type of Device: LABOR AND DELIVERY KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - SPT
• MDR Report Key: 14043251
• MDR Text Key: 288875356
• Report Number: MW5108814
• 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: Nurse
• Type of Report: Initial
• Report Date: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CMPJ05907
• Device Catalogue Number: CMPJ05907
• Device Lot Number: 211BF178
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White