MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; PACK,COLD,STANDARD,OB-PAD,4.5"X14.25"

Catalog Number	MDS138055
Health Effect - Clinical Code	Red Eye(s) (2038)
Date of Event	11/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the instant cold pack exploded while being activated by the patient's husband.No information was provided on how the instant cold pack was activated.The patient's husband reportedly received instructions on how to activate the pack from the nurse, who at the time of the incident was providing peri-care to the patient.Reportedly, when the instant cold pack exploded, its contents reached the eyes of the patient's husband.The patient's husband reportedly developed watery reddened eye irritation, which required immediate washout with eye irrigation solution.The patient's husband was then was sent to the emergency department for further evaluation where he reportedly received additional eye irrigation to remove the instant cold pack contents from his eyes.No serious injury was reported and the patient's husband was discharged with instructions to follow-up with his primary care doctor if eyes continued to be irritated.Prior to activation, there was reportedly no obvious damage to the instant cold pack.Due to the reported incident and the required eye irrigation, this medwatch is being filed.The sample is not available to be returned for evaluation.A definitive root cause could not be determined.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the patient's husband activated the cold pack and it exploded.The patient's husband required eye irrigation.

• Common Device Name: PACK,COLD,STANDARD,OB-PAD,4.5"X14.25"
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 9416168
• Report Number: 1417592-2019-00215
• Device Sequence Number: 2738805
• Product Code: IMD
• UDI-Device Identifier: 00080196733715
• UDI-Public: 00080196733715
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: MDS138055
• Device Lot Number: VN19208
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention