InjuryELM
MONDIAL
Received Sep 25, 2017
Report 3006610834-2017-00001 · MDR key 6891932
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Complaint, Ill-Defined
- Complaint, Ill-Defined
Narrative
Additional Manufacturer Narrative
AS ALLOWED BY EXEMPTION #E2013019, KULZER, LLC (THE IMPORTER) IS REPORTING ON BEHALF OF KULZER, GMBH (THE MANUFACTURER). ALTHOUGH WE HAVE NOT ESTABLISHED THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, THE INCIDENT WILL BE REPORTED TO MAINTAIN COMPLIANCE WITH 21 CFR 803 AND OUT OF AN ABUNDANCE OF CAUTION.
Description of Event or Problem
PATIENT COMPLAINS OF VAGUE ALLERGY SYMPTOMS.