MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. INFANT HELL WARMER; INFANT HELL WARMER (CHEMICAL HEAT PACK)

Model Number MDS138007

Device Problem Explosion (4006)

Patient Problem Chemical Exposure (2570)

Event Date 06/06/2021

Event Type  malfunction  

Event Description

An infant heel warmer from medline was activated by a nurse and subsequently exploded and the contents splattered on the nurses chest and face mask.The nurse immediately removed the liquid and no lasting harm was noted.Manufacturer response for infant heel warmer, (brand not provided) (per site reporter): representative was responsive and retrieved the product.We have requested an update on the outcome of the investigation.

• Brand Name: INFANT HELL WARMER
• Type of Device: INFANT HELL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline pl; mundelein IL 60060
• MDR Report Key: 12165682
• MDR Text Key: 261509464
• Report Number: 12165682
• Device Sequence Number: 1
• Product Code: MPO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MDS138007
• Device Lot Number: VN20337A1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/07/2021
• Event Location: Other
• Date Report to Manufacturer: 07/14/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1