MAUDE Adverse Event Report: OWENS MINOR DISTRIBUTION, INC. MEDICHOICE; PACK, HOT OR COLD, DISPOSABLE

Model Number CWP954

Device Problem Self-Activation or Keying (1557)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/30/2022

Event Type  malfunction  

Event Description

Ten warm packs in birthplace clean storage were found to be activated.

• Brand Name: MEDICHOICE
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): OWENS MINOR DISTRIBUTION, INC.; 6201 global distribution way ste 101; louisville KY 40228
• MDR Report Key: 15445577
• MDR Text Key: 300153584
• Report Number: 15445577
• Device Sequence Number: 1
• Product Code: IMD
• 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: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: CWP954
• Device Catalogue Number: CWP954
• Device Lot Number: 2205RA54A1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/07/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1