Plain Gut 5-0 18" PC-1 Conventional Cutting 3/8C 13mm B1915NRecalls & reported problems
Surgical Specialties México, S. de R.L. de C.V. · Plain Gut 5-0 18" PC-1 Conventional Cutting 3/8C 13mm · 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 00848782004744), received between Sep 3, 2025 and Sep 3, 2025 — 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Wound Dehiscence1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 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 DURING THE OPERATION, THE PATIENT DEHISCED. INTERVENTION WAS REQUIRED. ANTIBIOTIC WAS PRESCRIBED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Wound Dehiscence
MAUDE report 22956478 ↗
Other SUTURE, ABSORBABLE, NATURAL devices
- Chromic Gut GG-122Covidien LP · SUTURE, ABSORBABLE, NATURAL1 recall12 reports
- Chromic Gut G-1780KCovidien LP · SUTURE, ABSORBABLE, NATURAL1 recall8 reports
- Chromic Gut UG-202Covidien LP · SUTURE, ABSORBABLE, NATURAL1 recall7 reports
- Chromic Gut UG-203Covidien LP · SUTURE, ABSORBABLE, NATURAL1 recall6 reports
- Plain Gut SG-5686Covidien LP · SUTURE, ABSORBABLE, NATURAL1 recall6 reports
- Chromic Gut GG-123Covidien LP · SUTURE, ABSORBABLE, NATURAL1 recall6 reports
- Chromic Gut SG-5687GCovidien LP · SUTURE, ABSORBABLE, NATURAL1 recall6 reports
- Chromic Gut GG-121Covidien LP · SUTURE, ABSORBABLE, NATURAL1 recall3 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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