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

Model Number	MSC091040
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	04/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2023 a reaction was noted after placing skin affix after an excision of a breast mass.The reaction was described as redness and rash from axilla to mid arm.It was reported that due to this, keflex and benadryl were prescribed.It was reported that the individual is now "stable".A sample was requested to be returned for evaluation.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
Reaction requiring antibiotics and benedryl.

• 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: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17128896
• Report Number: 1417592-2023-00245
• Device Sequence Number: 7388353
• Product Code: MPN
• UDI-Device Identifier: 10884389953044
• UDI-Public: 10884389953044
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 06/14/2023

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
• Device Model Number: MSC091040
• Device Catalogue Number: MSC091040
• Device Lot Number: P00228685
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 06/14/2023
• 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: Other
• Patient Sex: Unknown