Dsm19 3-0 Und Br Pga 18"/45cm G497NRecalls & reported problems
Surgical Specialties México, S. de R.L. de C.V. · Dsm19 3-0 Und Br Pga 18"/45cm · 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 00848782015085), received between Jun 10, 2021 and Jun 10, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (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
- Migration or Expulsion of Device1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 10, 2021Migration or Expulsion of Device
THE PATIENT HAD A SEVERE CASE OF SPITTING OF HER SUTURES BILATERALLY ON HER VERTICAL BREAST INCISIONS AS WELL AS ON PARTS ON HER ABDOMEN (SHE HAD A MASTOPEXY WITH A REMOVAL AND PLACEMENT OF IMPLANTS ALONG WITH AN ABDOMINOPLASTY). SHE REQUIRED EXTENSIVE WOUND CARE POST OP AND HER INCISION TOOK OVER 5 WEEKS TO COMPLETELY HEAL. DR (B)(6) HAS NOT EXPERIENCED ANYTHING TO THIS DEGREE BEFORE DURING HIS TIME IN PRACTICE WITH HAS BEEN OVER 20 YEARS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11980232 ↗
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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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