MAUDE Adverse Event Report: MAXTEC, LLC EYEMAX2; PHOTOTHERAPY MASK

Model Number	R300P01-002
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Maxtec's complete complaint database was searched.The total available complaints date range was from (b)(6) 2017 - (b)(6) 2021.There were zero (0) complaints relating to a "slippery" eyemax2 regular (r300p01-002).The maude database was reviewed from (b)(6) 2019 to (b)(6) 2021, product code fok: there were a total of 4 reportable events, 3 out of the 4 events involved mask "slippage", 0 out of the 4 events involved the r300p01-002 eyemax2, 1 out of the 4 events involved an eyemax2.Maxtec will conduct a physical evaluation when the eyemax2 in question is obtained.The root cause is unknown.
Event or Problem Description
As described by the customer: first of all, we received a customer complaint about your eyemax product (regular).Our customers find that their eyemax (batch number: 044284-1) appeared to be more slippery than before.They need to reposition them regularly and even to make it hold by other means.It seems to be caused by the new material.They are afraid for the safety of the baby with the risk of eye burns.It seems that they are thinking about reporting a vigilance problem.

• Brand Name: EYEMAX2
• Common Device Name: PHOTOTHERAPY MASK
• Manufacturer (Section D): MAXTEC, LLC; 2305 south 1070 west; salt lake city UT 84119
• MDR Report Key: 11457394
• Report Number: 1000117260-2021-00002
• Device Sequence Number: 5424952
• Product Code: FOK
• UDI-Device Identifier: 00817770022039
• UDI-Public: 00817770022039
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/09/2021

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
• Operator of Device: Health Professional
• Device Model Number: R300P01-002
• Device Catalogue Number: R300P01-002
• Device Lot Number: 044284-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 03/10/2021
• 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: Other