VISORB 392ARecalls & reported problems
C.P. Medical Corporation · Class 2
Data updated Oct 16, 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 10790986000381), received between Sep 27, 2019 and Dec 11, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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 16, 2026.
Most reported problems
Device problems
- Break2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 11, 2019Break
IT WAS REPORTED SIZE 4/0 PGA SUTURE BREAKING DURING NORMAL PROCEDURE. (LOT# 181017-60). THE DISTRIBUTOR HAS BEEN CONTACTED SEVERAL TIMES AND HASN'T PROVIDED DETAILS OF THE EVENT. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MDR WILL BE SUBMITTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9454659 ↗MalfunctionSep 27, 2019Break
IT WAS REPORTED THAT SIZE 4/0 POLYGLYCOLIC ACID SUTURE BROKE DURING NORMAL PROCEDURE. (LOT# 190408-53) THE DISTRIBUTOR HAS BEEN CONTACTED SEVERAL TIMES AND HASN'T PROVIDED DETAILS OF THE EVENT. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MDR WILL BE SUBMITTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9131418 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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