DigniCap® Delta 900-1001Recalls & reported problems
Dignitana AB · DigniCap Delta System · Class 2
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00850036106005), received between Mar 13, 2025 and Oct 24, 2025 — classified as 7 injuries.
The most frequently reported specific device problem is “Use of Device Problem” (7 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
- Use of Device Problem7
Patient problems
- Burn(s)7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryOct 24, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED BURN INCLUDING PAIN AND ERYTHEMA TO BOTTOM PORTION OF HAIR LINE.
Patient problems: Burn(s)
MAUDE report 23377168 ↗InjuryAug 26, 2025Use of Device Problem; Use of Device Problem
InjuryAug 26, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THERE WAS A BURN ON THE TOP OF THE SCALP.
Patient problems: Burn(s)
MAUDE report 22892519 ↗InjuryJun 24, 2025Use of Device Problem; Use of Device Problem
InjuryMay 21, 2025Use of Device Problem; Use of Device Problem
InjuryApr 22, 2025Use of Device Problem; Use of Device Problem
InjuryMar 13, 2025Use of Device Problem; Use of Device Problem
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.