inforMED
InjuryFQM

BANDAGE KIT, COMPRESSION COMPRI2 LITE 9 3/4IN X 12 1/2IN

Received May 28, 2026 · Event occurred Apr 10, 2026

Report MW5188662 · MDR key 25318454

Device

Generic name

Bandage, Elastic

Manufacturer

Bsn Medical, Inc.

Lot number

540264

Product problems

  • Device Emits Odor
  • Device Contaminated During Manufacture or Shipping

Patient

65 YR · Male

  • Inflammation
  • Itching Sensation

Narrative

Description of Event or Problem

REPORT: (B)(4): LLT CODES: 10069327:PRODUCT QUALITY ISSUE I NARRATIVE: PRODUCT PROBLEM: VETERAN REPORTED TO NURSE THAT THE LAST 2 SHIPMENTS OF COMPRI2 LITE COMPRESSION WRAPS HAVE SMELLED MOLDY WHEN THEY OPEN THE BOX. HE SAYS THEY DON'T LOOK MOLDY, BUT THE SMELL IS NOTICEABLE ESPECIALLY WHEN OPENING THE WHITE WRAP. HE REPORTED HE USED ONE OF THE SET BUT IT CAUSED ITCHING AND INFLAMMATION SO HE REMOVED IT. PHARMACY WILL SEND REPLACEMENT SUPPLY AS REQUESTED. PATIENT HAS USED THIS SUPPLY ITEM SINCE 2025. NO PRIOR COMPLAINTS RECEIVED WITHIN PHARMACY. DIAGNOSIS FOR USE: COMPLEX SIG ORDER (PROD 1): USE BANDAGE TOPICALLY EVERY 96 HOURS FOR COMPRESSION. PT: 1943, 1932. DEVICE: 2969, 1425. REF: MW5188663.