inforMED
InjuryKCZ

AMOENA

Received Jun 13, 1998 · Event occurred Jul 15, 1997

Report 1046831-1998-00001 · MDR key 172329

Device

Generic name

External Breast Prosthesis

Manufacturer

Coloplast Corp

Model number

802

Catalog number

UNK

Lot number

UNK

Product problems

  • Material Rupture

Patient

78 YR

  • Bacterial Infection
  • Cellulitis
  • Erythema
  • Pain
  • Swelling
  • Caustic/Chemical Burns
  • Treatment with medication(s)

Narrative

Description of Event or Problem

THE SEAM OF THE EXTERNAL BREAST PROSTHESIS RUPTURED CAUSING SILICONE TO COME IN CONTACT WITH THE SKIN ON PT'S CHEST WALL. PT CLAIMS CHEST TURNED RED AS A RESULT OF A CHEMICAL BURN. PT WAS TAKEN TO THE HOSP FOR BACK SURGERY DUE TO HERNIATED LUMBAR DISK. WHILE PREPARING FOR SURGERY, DR NOTED PAIN, REDNESS AND SWELLING OF THE RIGHT ARM OF THE PT AND DIAGNOSED BACTERIAL CELLULITIS, ALLEGEDLY CAUSED BY THE BREAST PROSTHESIS RUPTURING. THE PT WAS GIVEN AN ANTIBIOTIC (ANCEF 2.0 GRAMS INTRAVENOUSLY EVERY EIGHT HOURS) AND THE BACTERIAL CELLULITIS RESOLVED.

Remedial action

  • Other