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

Catalog Number	MSC091040
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	08/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was initially reported that an unknown number of patients had dehiscence of their laparoscopic wounds.Reportedly, these wounds were closed using skin affix.It was added that the reported incidents of dehiscence of laparoscopic wounds were not specific to any user or patients.Despite good faith efforts to obtain additional information, no further patient, product, procedural or event details are available.Per report, the surgeons have switched to using liquid adhesive and steri strips and have had no problems.Due to the reported dehiscence, this medwatch is being filed.The lot number is not available.Companion samples had not been returned for evaluation.A definitive root cause for the reported issue could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that an unknown number of patients had dehiscence of their laparoscopic wounds, which were closed using skin affix.

• 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: 8956132
• Report Number: 1417592-2019-00153
• Device Sequence Number: 14053256
• Product Code: MPN
• UDI-Device Identifier: 10884389953044
• UDI-Public: 10884389953044
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date (Section B): 09/03/2019

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 Catalogue Number: MSC091040
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 09/03/2019
• 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