MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NORTHFIELD MEDLINE INSTANT HOT PACK; PACK, HOT OR COLD, DISPOSABLE

Model Number MDS139008

Device Problem Material Rupture (1546)

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

Event Date 10/23/2022

Event Type  malfunction  

Event Description

Hot pack was activated by rn by squeezing.She squeezed the pack before applying to the patient.It exploded at seam.It did not reach the patient.Nurse was not harmed and did not need further treatment.Fda safety report id # (b)(4).

• Brand Name: MEDLINE INSTANT HOT PACK
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NORTHFIELD
• MDR Report Key: 15708006
• MDR Text Key: 302875122
• Report Number: MW5112986
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MDS139008
• Device Catalogue Number: MDS139008
• Device Lot Number: VN21894-78
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1