Dsm19 4-0 Bk Mono Nyl 18"/45cm A1667NRecalls & reported problems
Surgical Specialties México, S. de R.L. de C.V. · Dsm19 4-0 Bk Mono Nyl 18"/45cm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00848782010035), received between Dec 3, 2025 and Dec 5, 2025 — classified as 4 injuries.
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 Problem4
Patient problems
- Wound Dehiscence4
- Pain1
- Swelling/ Edema1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED ON (B)(6) 2025 THAT WOUND DEHISCENCE OCCURRED POST-OPERATIVELY. TREATMENT REPORTED WAS SUTURE REMOVAL. NO OTHER INFORMATION WAS RECEIVED.
Patient problems: Wound Dehiscence
MAUDE report 23728205 ↗InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED ON (B)(6) 2025 THAT WOUND DEHISCENCE OCCURRED POST-OPERATIVELY. TREATMENT REPORTED WAS REMOVAL OF SUTURES AND ANTIBIOTICS. NO OTHER INFORMATION WAS RECEIVED.
Patient problems: Pain; Swelling/ Edema; Wound Dehiscence
MAUDE report 23723191 ↗InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED ON (B)(6) 2025 THAT WOUND DEHISCENCE OCCURRED POST-OPERATIVELY. TREATMENT REPORTED WAS SUTURE REMOVAL, STERI-STRIPS APPLIED FOR "ADDITIONAL SUPPORT", AND ANTIBIOTICS PRESCRIBED TO PREVENT INFECTION. WOUND HEALING BY SECONDARY INTENTION. NO OTHER INFORMATION WAS RECEIVED.
Patient problems: Wound Dehiscence
MAUDE report 23711359 ↗InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED ON (B)(6) 2025 THAT WOUND DEHISCENCE OCCURRED POST-OPERATIVELY. TREATMENT REPORTED WAS ANTIBIOTICS. NO OTHER INFORMATION WAS RECEIVED.
Patient problems: Wound Dehiscence
MAUDE report 23710952 ↗
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- 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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