MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. - LAREDO LAP CHOLE PACK; LAPAROSCOPY KIT

Model Number DYNJ49351

Device Problem Complete Blockage (1094)

Patient Problem Insufficient Information (4580)

Event Date 07/09/2021

Event Type  malfunction  

Event Description

The "fog reduction device" tip, in the medline lap chole pack, is blocked from the manufacturer.Fda safety report id# (b)(4).

• Brand Name: LAP CHOLE PACK
• Type of Device: LAPAROSCOPY KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC. - LAREDO
• MDR Report Key: 12160903
• MDR Text Key: 261661908
• Report Number: MW5102498
• Device Sequence Number: 1
• Product Code: FDE
• 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: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: DYNJ49351
• Device Catalogue Number: DYNJ49351
• Device Lot Number: 21DBS082
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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 Age: 74 YR