DeScribe Transparent PFD Patch 5035837Recalls & reported problems
Merz North America, Inc. · Individually packaged DeScribe PFD Patch (each) · Class 2
Data updated Oct 16, 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 00186295000359), received between Sep 26, 2018 and Sep 26, 2018 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Scarring1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS SPONTANEOUS REPORT WAS RECEIVED FROM A REGISTERED NURSE AT A LASER CENTER AND CONCERNS A FEMALE PATIENT WHO IS A TECHNICIAN AT THE OFFICE WHO WAS USING A LASER AND THE DESCRIBE PATCH ON (B)(6) 2018. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS NOT REPORTED. DURING THE PROCEDURE, THE TECHNICIAN REMOVED HER GOGGLES AND PERFORMED THE LAST LASER PASS WITHOUT THEM. SHE COULD NOT SEE CLEARLY AND NOTED SOME TYPE OF REFLECTION OFF OF THE PATCH. SHE WAS SEEING DARK SPOTS. THE PATIENT PRESENTED TO AN OPHTHALMOLOGIST (ALSO REPORTED AS AN OPTOMETRIST) FOR EVALUATION. FOLLOW UP INFORMATION WAS RECEIVED FROM THE REPORTER VIA TELEPHONE ON (B)(6) 2018: THE PATIENT HAS CONTINUED TO SEE A RETINA SPECIALIST. HER SYMPTOMS ARE IMPROVING WITH TIME. FOLLOW UP INFORMATION WAS RECEIVED FROM THE REPORTER VIA FAX ON (B)(6) 2018: THE PATIENT'S INITIALS AND AGE WERE PROVIDED. MEDICAL HISTORY REPORTED AS NEGATIVE. PATIENT IS A FITZPATRICK SKIN TYPE II. THE (B)(6) -YEAR-OLD PATIENT/LASER TECHNICIAN REMOVED HER GOGGLES DURING A TATTOO REMOVAL PROCEDURE TO OBSERVE A PULSE THROUGH THE DESCRIBE PFD PATCH, WHICH WAS BEING USED WITH A Q SWITCH LASER. SHE FELT A "POP" IN HER EYE (SIDE NOT SPECIFIED) AND, SHORTLY TH
Patient problems: Scarring
MAUDE report 7911702 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page