MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DISPOSABLE FACE MASK (CASE OF 8); ACCESSORIES, OPERATING-ROOM, TABLE (KIT)

Model Number	7210559
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Abrasion (1689); Injury (2348)
Date of Event	10/06/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after surgery when the face mas was used, dermal damage was confirmed on the cheek of the patient.The patient had been positioned for less than 2 hours during surgery and the adjustment of patient position and face mask.No further complications reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).The reported device, used in treatment, was not returned to the designated complaint facility for independent evaluation, thus visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined.No product identification information was provided and thus a manufacturing record review could not be conducted.A complaint history review for ¿dermal damage¿ complaints associated with the reported part number identified no similar events in the last three years.It was determined this was an isolated event.A review of the customer images confirmed dermal damage to the patient.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.The t-max instructions for use warns, ¿ensure face mask is not applying pressure on the patient¿s eyes and pressure on the face is evenly distributed¿ and ¿do not over tighten straps holding chin in place and ensure there is no pressure on structures under the chin.When the patient is lowered, the head will slide down the headset pad.The face mask must be released when the patient is raised or lowered.¿ a review of the t-max risk management files was performed and found multiple line items addressing this failure mode.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: DISPOSABLE FACE MASK (CASE OF 8)
• Common Device Name: ACCESSORIES, OPERATING-ROOM, TABLE (KIT)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 10737816
• Report Number: 1643264-2020-01615
• Device Sequence Number: 1767858
• Product Code: FWZ
• UDI-Device Identifier: 03596010513724
• UDI-Public: 03596010513724
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2020

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: Health Professional
• Device Model Number: 7210559
• Device Catalogue Number: 7210559
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 10/26/2020
• Supplement Report FDA Received Date: 12/07/2020
• 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