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 CorpModel number
802Catalog 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