MAUDE Adverse Event Report: PACKROOM LLC HUNTSVILLE LAP CHOLE; LAPAROSCOPY KIT

Model Number HH270

Device Problem Packaging Problem (3007)

Patient Problem Insufficient Information (4580)

Event Date 04/20/2022

Event Type  malfunction  

Event Description

Pack room llc sent a lap chole pack that had 2 packs of raytexs in it.It is supposed to only come with one pack of raytex.Manufacturer response for laparoscopic cholecystectomy, (huntsville lap chole) (per site reporter) no response has been received at this time.

• Brand Name: HUNTSVILLE LAP CHOLE
• Type of Device: LAPAROSCOPY KIT
• Manufacturer (Section D): PACKROOM LLC; 1281 highway 155 south; mc donough GA 30253
• MDR Report Key: 14186195
• MDR Text Key: 289872266
• Report Number: 14186195
• Device Sequence Number: 1
• Product Code: FDE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: HH270
• Device Catalogue Number: HH270.01
• Device Lot Number: 31400
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/20/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1