MAUDE Adverse Event Report: MEDLINE INDUSTRUIES LP Medline; SKIN AFFIX SURG ADHESIVE 12/BOX 0.55ML

Model Number	MSC091040
Health Effect - Clinical Codes	Wound Dehiscence (1154); Unspecified Infection (1930)
Date of Event	07/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a procedure the product was applied and the patient experienced dehiscence of the incision and an infection.Further medical intervention was required.
Additional Manufacturer Narrative
(pt.1 of 3) it was reported that the patient experienced implantation of a st.Jude loop recorder.The skin affix was applied after the procedure was completed.The patient reported discomfort at the site within 3 days of the implant.The patient was brought back for a wound site inspection on day 7 all of which the patient had dehiscence of the incision.The patient required 10-14 days of (unspecified) antibiotic therapy and explant of the device in a hospital operating room occurred 14-21 days post implant.The customer reportedly used all of the remaining product and no sample was returned for evaluation.No additional information is available.Due to the reported incident and 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.

• Brand Name: Medline
• Common Device Name: SKIN AFFIX SURG ADHESIVE 12/BOX 0.55ML
• Manufacturer (Section D): MEDLINE INDUSTRUIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 12840246
• Report Number: 1417592-2021-00207
• Device Sequence Number: 11841678
• Product Code: MPN
• UDI-Device Identifier: 10884389953044
• UDI-Public: 10884389953044
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/18/2021

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: MSC091040
• Device Catalogue Number: MSC091040Z
• Device Lot Number: P00221857
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 11/18/2021
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Unknown
• Patient Weight: 153 KG