SurgiSeal SS-050SRecalls & reported problems
Adhezion Biomedical, LLC · SurgiSeal Stylus topical skin adhesive · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M495SS050S1), received between Jan 31, 2017 and Jan 31, 2017.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Improper or Incorrect Procedure or Method1
Patient problems
- Wound Dehiscence1
- Wound Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
Jan 31, 2017Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem
"A SALES REPRESENTATIVE MENTIONED THAT A MATERIAL MANAGER REPORTED, THAT A PATIENT HAD AN INFECTION AND THE WOUND OPENED UP ON USING SURGISEAL STYLUS."
Patient problems: Wound Dehiscence; Wound Infection
MAUDE report 6291711 ↗
Other Tissue Adhesive For The Topical Approximation Of Skin devices
- DERMABOND ADVANCED DNX12Ethicon, LLC · Tissue adhesive for the topical approximation of skin1 recall439 reports
- McKesson 122-LBXSMckesson Medical-Surgical Inc. · Tissue Adhesive For The Topical Approximation Of Skin1 recall0 reports
- McKesson 122-LFCMckesson Medical-Surgical Inc. · Tissue Adhesive For The Topical Approximation Of Skin1 recall0 reports
- McKesson 122-LBXMckesson Medical-Surgical Inc. · Tissue Adhesive For The Topical Approximation Of Skin1 recall0 reports
- DERMABOND DHVM12Ethicon, LLC · Tissue adhesive for the topical approximation of skin44 reports
- DERMABOND ADVANCED DNX6Ethicon, LLC · Tissue adhesive for the topical approximation of skin13 reports
- Medline MSC091040Medline Industries, Inc. · Tissue adhesive for the topical approximation of skin13 reports
- LiquiBand Exceed LX6Covidien LP · Tissue adhesive for the topical approximation of skin7 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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