2-0 Uni Monoderm 20cm VLM-1006Recalls & reported problems
Surgical Specialties México, S. de R.L. de C.V. · 2-0 Uni Monoderm 20cm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00848782020119), received between Oct 24, 2022 and Oct 24, 2022 — classified as 1 injury.
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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Post Operative Wound Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 24, 2022Adverse Event Without Identified Device or Use Problem
WOUND HEALING DIFFICULTY, NO DETAILS WERE INITIALLY RECEIVED ADRS# REPORT CODE (B)(4) UPDATED 10/14 THE PATIENT UNDERWENT SURGERY FOR APPENDICITIS ON (B)(6) 2021. THE APPENDIX WAS REMOVED, AND THE INCISION WAS SUTURED. BUT THE WOUND DID NOT RECOVER, AND INFECTION WAS SEEN DURING THE HOT WEATHER. HE CAME TO THE HOSPITAL FOR A REVIEW ON (B)(6) 2021.
Patient problems: Post Operative Wound Infection
MAUDE report 15663811 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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