MalfunctionFOX
STATLOCK CV PLUST SLIDING POST, PIGTAIL PAD
Received Jan 20, 2021 · Event occurred Jul 8, 2020
Report 3006260740-2021-00040 · MDR key 11205529
Device
Generic name
Stand, Infusion
Manufacturer
C.r. Bard, Inc. (basd) -3006260740Catalog number
CV0220CE
Lot number
JUCZF323
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
59 YR
- Inflammation
- Inflammation
Narrative
Additional Manufacturer Narrative
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF JUCZF323 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.
Description of Event or Problem
IT WAS REPORTED DURING THE TREATMENT OF THE PATIENT, AN ALLERGIC REACTION OCCURRED AT THE CONTACT SITE OF THE APPLIANCE AND THE SKIN. AFTER ADEQUATE EXPOSURE, THE SKIN SYMPTOMS IMPROVED. NO OTHER INFORMATION WAS PROVIDED.