INSET GUARD
Received Jul 10, 2026
Report 8021545-2026-21740 · MDR key 25775429
Device
Generic name
Set, Administration, Intravascular
Manufacturer
Unomedical A/sModel number
NERIA GUARD UNKNOWNLot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Skin Infection
- Swelling/ Edema
Narrative
Additional Manufacturer Narrative
BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. REQUEST WAS PERFORMED FOR ADDITIONAL INFORMATION INCLUDING LOT NUMBER; HOWEVER, LOT NUMBER WAS NOT PROVIDED. A COMPLAINT INVESTIGATION WAS INITIATED UNDER COMPLAINT INVESTIGATION. UNFORTUNATELY, NO SPECIFIC LOT NUMBER WAS IDENTIFIED, WHICH LIMITS THE ABILITY TO TRACE OR ANALYZE A PARTICULAR ITEM. INVESTIGATION IN PROGRESS. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: 8021545, MANUFACTURING SITE: 8021545.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AT SWOLLEN AREA ON ABDOMEN WITH FLUID FILLED SAC. IT WAS DARK PINK TO PURPLISH IN COLOR. NOTIFIED HCP AND ORAL ANTIBIOTICS WERE GIVEN.