MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 1998-06-13 for AMOENA 802 UNK manufactured by Coloplast Corp.
[104386]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1046831-1998-00001 |
| MDR Report Key | 172329 |
| Report Source | 04 |
| Date Received | 1998-06-13 |
| Date of Report | 1998-06-02 |
| Date of Event | 1997-07-15 |
| Date Mfgr Received | 1998-06-02 |
| Date Added to Maude | 1998-06-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMOENA |
| Generic Name | EXTERNAL BREAST PROSTHESIS |
| Product Code | KCZ |
| Date Received | 1998-06-13 |
| Model Number | 802 |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 167569 |
| Manufacturer | COLOPLAST CORP |
| Manufacturer Address | 1955 WEST OAK CIRCLE MARIETTA GA 300622249 US |
| Baseline Brand Name | AMOENA |
| Baseline Generic Name | EXTERNAL BREAST PROSTHESIS |
| Baseline Model No | 802 |
| Baseline Catalog No | 5802 |
| Baseline ID | NA |
| Baseline Device Family | PROSTHETICS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1998-06-13 |