MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; SKIN AFFIX SURG ADHESIVE 72/CS .4ML

Catalog Number	MSC091040
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	05/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that a patient, who had an unidentified abdominal surgery which used the skin affix to close a wound, returned to the emergency department "with what appeared to be infected wound with necrotic tissue covering the wound bed".Despite good faith efforts to obtain additional information, the reporter was unable or unwilling to provide any further patient, product, or procedural details.The reporting facility did not provide an actual diagnosis and what medical intervention was required for the reported incident.Due to the reported incident and in an abundance of caution, this medwatch is being filed.The sample is not available to be returned for evaluation.A root cause cannot be determined at this time.No additional information is available.If additional relevant information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a patient who had an unidentified abdominal surgery which used the skin affix to close a wound returned to the emergency department "with what appeared to be infected wound with necrotic tissue covering the wound bed".

• Common Device Name: SKIN AFFIX SURG ADHESIVE 72/CS .4ML
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7581853
• Report Number: 1417592-2018-00053
• Device Sequence Number: 2062804
• Product Code: MPN
• UDI-Device Identifier: 10884389953044
• UDI-Public: 10884389953044
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/08/2018

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: Other
• Device Catalogue Number: MSC091040
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2018
• Initial Report FDA Received Date: 06/08/2018
• 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