MAUDE Adverse Event Report: COOPERSURGICAL, INC.; PACK, HOT OR COLD, DISPOSABLE

Lot Number IL091

Device Problems Insufficient Heating (1287); Activation Failure (3270)

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

Event Date 06/11/2022

Event Type  malfunction  

Event Description

The transwarmer did not heat up when activated, the normal reaction occurred where the clear gel turns white but the mattress never warmed up.It had not previously accidently been activated either.

• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 15146058
• MDR Text Key: 297063373
• Report Number: 15146058
• 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: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: IL091
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/21/2022
• Event Location: Other
• Date Report to Manufacturer: 08/02/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1