MAUDE Adverse Event Report: DENOVO PRODUCTS LLC GEL INFANT HEEL WARMER; INFANT HEEL WARMER (CHEMICAL HEAT PACK)

Model Number 355NW

Device Problem Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/30/2017

Event Type  malfunction  

Event Description

Upon flexing the metal disc to active the product, the disc ruptured the bag.Manufacturer response for gel infant heel warmer, (brand not provided) (per site reporter).Manufacturer contacted early october.They advised for me to discard product rather than send back for investigation.They advised disc was likely flexed too aggressively which fractured the device.

• Brand Name: GEL INFANT HEEL WARMER
• Type of Device: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): DENOVO PRODUCTS LLC; 17051 alico commerce court; unit 3; fort myers FL 33967
• MDR Report Key: 6950987
• MDR Text Key: 89369240
• Report Number: 6950987
• Device Sequence Number: 1
• Product Code: MPO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/02/2017

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: Nurse
• Device Expiration Date: 08/03/2019
• Device Model Number: 355NW
• Device Catalogue Number: 355NW
• Device Lot Number: 080317A
• 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: 10/02/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/02/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1