2dsl6 10-0 Bkmono Nyl 12"/30cm A7770NRecalls & reported problems
Surgical Specialties México, S. de R.L. de C.V. · 2dsl6 10-0 Bkmono Nyl 12"/30cm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00848782010738), received between Apr 8, 2021 and Apr 21, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Separation Problem” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Separation Problem1
- Therapeutic or Diagnostic Output Failure1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 21, 2026Adverse Event Without Identified Device or Use Problem; Separation Problem
IT WAS REPORTED ON 9 APRIL 2026 THAT THE PATIENT EXPERIENCED AN ALLERGIC REACTION TO AN UNKNOWN SUTURE. NO ADDITIONAL INFORMATION WAS RECEIVED.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 24944332 ↗InjuryApr 8, 2021Therapeutic or Diagnostic Output Failure
THE PATIENT WAS HOSPITALIZED AFTER BEING DIAGNOSED WITH CATARACT AND GLAUCOMA WITHIN BOTH EYES. ON (B)(6) 2020, COMBINED SURGERY OF GLAUCOMA AND CATARACT WERE PERFORMED ON THE PATIENT. LIQUID LEAKAGE WAS DETECTED AFTER SUTURING AND ANOTHER SUTURING PROCESS WAS IMMEDIATELY PERFORMED. NO LEAKAGE WAS DETECTED AFTER THE SECOND SUTURING PROCESS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11638985 ↗
Other SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE devices
- ETHILON 697GEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE223 reports
- ETHILON 698GEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE119 reports
- ETHILON 1696GEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE118 reports
- Monosof SN-3695Covidien LP · SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE2 recalls3 reports
- McKesson S661GXMckesson Medical-Surgical Inc. · Suture, Nonabsorbable, Synthetic, Polyamide2 recalls2 reports
- Surgilon 88861919-41Covidien LP · SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE2 recalls2 reports
- McKesson S931BXMckesson Medical-Surgical Inc. · Suture, Nonabsorbable, Synthetic, Polyamide2 recalls2 reports
- McKesson S697GXMckesson Medical-Surgical Inc. · Suture, Nonabsorbable, Synthetic, Polyamide2 recalls1 report
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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