KALTOSTAT 168214Recalls & reported problems
Convatec, Purchasing Department · KALTOSTAT DRS WT 10X20CM 1X10PK STER US · Class 1
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00768455122813), received between Nov 8, 2023 and Nov 8, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Nonstandard Device” (3 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Nonstandard Device3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 8, 2023Nonstandard Device; Nonstandard Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18094124 ↗MalfunctionNov 8, 2023Nonstandard Device; Nonstandard Device
TO DATE, ADDITIONAL PATIENT OR EVENT DETAILS WERE RECEIVED WHICH HAVE BEEN ADDED IN H10 (ADDL MFG NARRATIVE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18094120 ↗MalfunctionNov 8, 2023Nonstandard Device; Nonstandard Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18094116 ↗
Other Dressing, Wound, Hydrophilic devices
- MEDLINE INDUSTRIES, INC. MSC7044EPMedline Industries, Inc. · Dressing, wound, hydrophilic1 recall1 report
- McKesson 3561Mckesson Medical-Surgical Inc. · Dressing, Wound, Hydrophilic1 recall0 reports
- McKesson 3562Mckesson Medical-Surgical Inc. · Dressing, Wound, Hydrophilic1 recall0 reports
- McKesson 3563Mckesson Medical-Surgical Inc. · Dressing, Wound, Hydrophilic1 recall0 reports
- McKesson 87400Mckesson Medical-Surgical Inc. · Dressing, Wound, Hydrophilic1 recall0 reports
- DuPad® 87810Derma Sciences Canada Inc · Dressing, wound, hydrophilic1 recall0 reports
- McKesson 3564Mckesson Medical-Surgical Inc. · Dressing, Wound, Hydrophilic1 recall0 reports
- MAXORB EXTRA AlginateMedline Industries, Inc. · Dressing, Wound, Hydrophilic1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.