Hu-Friedy Mfg. Co., LLC PSN8385PRecalls & reported problems
Hu-Friedy Mfg. CO., LLC · 5-0 BLUE POLYPROPYLENE SUTURE 18", C-17 NEEDLE 12MM, 3/8 CIRCLE REVERSE CUT · Class 2 · Implant
Data updated Oct 18, 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 10889950001872), received between Jan 6, 2023 and Jan 6, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Laceration(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
THE USER FACILITY REPORTED THAT DURING A DENTAL PROCEDURE THE NEEDLE ON THE PSN8385P SUTURE BROKE; THE COMPONENTS OF THE BROKEN NEEDLE WERE RETRIEVED IMMEDIATELY. IT WAS OBSERVED THAT THE PATIENT HAD CUTS ON THE INSIDE OF THEIR CHEEK AROUND THE SUTURE AREA. THE PATIENT WAS TREATED WITH ORACORT (DENTAL PASTE).
Patient problems: Laceration(s)
MAUDE report 16113187 ↗
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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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