MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC ACCU-THERM DELUXE HOT PACK; PACK, HOT OR COLD, DISPOSABLE

Catalog Number MDS14900

Device Problems Material Rupture (1546); Activation, Positioning or Separation Problem (2906); Explosion (4006)

Patient Problems Dry Eye(s) (1814); Chemical Exposure (2570)

Event Date 06/05/2020

Event Type  malfunction  

Event Description

Two hot pack explosions on a nursing unit in the same day.During the first event, the rn tried 3 times to activate the hot pack (attempts unsuccessful).On the 4th try, the pack ruptured/exploded, and fluid got in the patient's eyes.The rn was approx.3 feet from patient when this occurred.The patient's eyes were immediately irrigated with normal saline for > 15 minutes and an ophthalmology consult was obtained.Ophthalmology recommended use of artificial tears and/or erythromycin ointment in both eyes qid (4 times daily) to relieve mild dryness of the ocular surface (no further evidence of chemical damage noted) and recommended follow-up in several weeks.During the second event, a unit support staff member was attempting to activate a hot pack in the hallway outside a patient's room.The pack exploded and its contents landed on the staff member, floor, and wall.The staff member was not harmed and there were no patients in the vicinity.All packs from this lot were sequestered and returned to the manufacturer with feedback given to manufacturer by our materials management department.Feedback based on event reviews: -users report that recommended method of activation (i.E., folding in half at dotted line) is not intuitive, particularly when the pack doesn't activate the first time a user folds it.-recommend making activation instructions clearer and including prominent warning labels regarding: potential harm to users/others in vicinity during activation and advising to keep packs away from face when activating, and against using twisting motions, applying excessive force, etc.

• Brand Name: ACCU-THERM DELUXE HOT PACK
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC; one medline pl; mundelein IL 60060
• MDR Report Key: 12165687
• MDR Text Key: 261509340
• Report Number: 12165687
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/06/2021,03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MDS14900
• Device Lot Number: UN19332-56
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/06/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18980 DA
• Patient Weight: 66