MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline; SKIN AFFIX SURG ADHESIVE 72/CS 0.55ML

Model Number	MSC091040
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	11/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on (b)(6) 2022 after a surgical case was complete "the scrub tech activated skinaffix by squeezing it and a piece of glass came through the plastic outer coating and stuck in their right thumb".Per the facility they removed their gloves, washed their hands, and cleaned the area with alcohol.Per the facility the staff member went to the emergency room where "the wound was explored, sutures were placed, and antibiotics and pain meds were given".Per the facility the staff member is reported to be doing "fine".A photo was provided for evaluation, however, a definitive root cause could not be determined.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the facility on (b)(6) 2022 after a surgical case was complete "the scrub tech activated skinaffix by squeezing it and a piece of glass came through the plastic outer coating and stuck in their right thumb".

• Brand Name: Medline
• Common Device Name: SKIN AFFIX SURG ADHESIVE 72/CS 0.55ML
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16130987
• Report Number: 1417592-2023-00021
• Device Sequence Number: 7636246
• Product Code: MPN
• UDI-Device Identifier: 10884389953044
• UDI-Public: 10884389953044
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/10/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: MSC091040
• Device Catalogue Number: MSC091040
• Device Lot Number: P00225542
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2022
• Initial Report FDA Received Date: 01/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown