2-0 Uni Pdo 15cm VLP-2022Recalls & reported problems
Surgical Specialties México, S. de R.L. de C.V. · 2-0 Uni Pdo 15cm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00848782023677), received between Apr 19, 2022 and Mar 16, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Device Fell1
- Loose or Intermittent Connection1
Patient problems
- Needle Stick/Puncture1
- 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.
MalfunctionMar 16, 2023Loose or Intermittent Connection
THE NEEDLE CAME LOOSE AND WENT INTO THE PATIENT''S BELLY.
Patient problems: Needle Stick/Puncture
MAUDE report 16562103 ↗MalfunctionApr 19, 2022Detachment of Device or Device Component; Device Fell
THE NEEDLE CAME OFF THE THREAD SEVERAL TIMES WHEN THE NFC WAS PULLED OUT THROUGH THE TROCAR AFTER CLOSURE OF THE PERITONEUM DURING A TAP. IN THE PROCESS, THE NEEDLE CAME OFF THE THREAD AND FELL INTO THE ABDOMEN. THE NEEDLE WAS RECOVERED. NO INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14152154 ↗
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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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