MAUDE Adverse Event Report: MEDLINE INDUSTRIES - ARLINGTON HEIGHTS ADDIPAK, 5ML STERILE 0.9% NACL (SALINE); NEBULIZER (DIRECT PATIENT INTERFACE)

Lot Number 1B024

Device Problem Off-Label Use (1494)

Patient Problems Burning Sensation (2146); Eye Burn (2523)

Event Date 11/12/2021

Event Description

Consumer has been using addipak single use 5 ml sterile 0.9% nacl with their scleral hard contact lenses, for a few years without issue.The consumers doctor recommended the use of this product in an off-label manner.The consumer purchased 2 new boxes of addipak in late (b)(6) 2021 and began use of the new boxes in (b)(6) 2021.Upon the first use of the addipak saline from the new boxes/lot the consumer stated they noted an immediate burning and eye irritant, like a chemical reaction.Complaint # (b)(4).

• Brand Name: ADDIPAK, 5ML STERILE 0.9% NACL (SALINE)
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): MEDLINE INDUSTRIES - ARLINGTON HEIGHTS
• MDR Report Key: 12933998
• MDR Text Key: 281907526
• Report Number: MW5105801
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 34026704628149
• UDI-Public: 34026704628149
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Expiration Date: 02/09/2023
• Device Lot Number: 1B024
• Patient Sequence Number: 1