MAUDE Adverse Event Report: COOPERSURGICAL, INC. TRANSWARMER INFANT TRANSPORT MATTRESS WITH WARM GEL; PACK, HOT OR COLD, DISPOSABLE

Lot Number 1K765

Device Problems Premature Activation (1484); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 08/22/2021

Event Type  No Answer Provided  

Event Description

The complainant reported to the (b)(6) on (b)(6) 2021, at the (b)(6) medical center that: "3 infant transport mattresses were found already activated when removed from the case.The infant transport mattresses are normally soft clear gel but these were cloudy white and hard.These mattresses were just ordered to replace the deroyal infant thermal mattresses (hnicu-200) because we had complaints about them being difficult to activate.We wanted to make sure that we could find a similar product in our prime vendor system because we completely removed the deroyal from service.".

• Brand Name: TRANSWARMER INFANT TRANSPORT MATTRESS WITH WARM GEL
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): COOPERSURGICAL, INC.
• MDR Report Key: 12562116
• MDR Text Key: 274927580
• Report Number: MW5104323
• Device Sequence Number: 1
• Product Code: IMD
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 09/08/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 1K765
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1