Medline Industries, Inc. DYNJ0378325ORecalls & reported problems
Medline Industries, Inc. · C SECTION PACK-LF · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10195327626976), received between Aug 27, 2024 and Sep 9, 2024 — classified as 12 injuries.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (4 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available8
- Patient Device Interaction Problem4
Patient problems
- Skin Inflammation/ Irritation10
- Rash3
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
InjurySep 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE FACILITY ON (B)(6) 2024, AN ABDOMINAL RASH WAS REPORTED.
Patient problems: Rash
MAUDE report 20175846 ↗InjurySep 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE FACILITY ON (B)(6) 2024, AN ABDOMINAL RASH WAS REPORTED.
Patient problems: Rash
MAUDE report 20175183 ↗InjurySep 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE FACILITY ON (B)(6) AN ABDOMINAL RASH WAS REPORTED. DUE TO THIS, A MEDROL DOSE PACK AND CREAM WAS USED.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 20170833 ↗InjurySep 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE FACILITY ON 5/24 AN ABDOMINAL RASH WAS REPORTED.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 20170502 ↗InjurySep 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE FACILITY ON 4/9 AN ABDOMINAL RASH WAS REPORTED.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 20170120 ↗InjurySep 6, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
InjurySep 6, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
InjurySep 5, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
InjurySep 5, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE FACILITY ON 6/2 AN ABDOMINAL RASH WAS REPORTED.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 20150007 ↗InjurySep 5, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE FACILITY ON 5/31 AN ABDOMINAL RASH WAS REPORTED.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 20149420 ↗InjurySep 5, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE FACILITY ON 5/10 AN ABDOMINAL RASH WAS REPORTED.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 20148680 ↗InjuryAug 27, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
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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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