MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2000-11-03 for AMOENA 880-8R 880 manufactured by Coloplast Corp..
[200749]
The complainant alleges in 2000 that they started having chills. The complainant's relative allegedly noticed complainant had a rash on complainant's chest where they had a mastectomy. Complainant said complainant was admitted to the hosp and diagnosed with cellulitis. Complainant alleges that this caused the complainant to go into septic shock.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2125337-2000-00001 |
| MDR Report Key | 303293 |
| Report Source | 04 |
| Date Received | 2000-11-03 |
| Date of Report | 2000-09-25 |
| Date of Event | 2000-01-11 |
| Date Mfgr Received | 2000-10-04 |
| Date Added to Maude | 2000-11-08 |
| 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 |
| Manufacturer Contact | HARVEY ARBIT |
| Manufacturer Street | 1940 COMMERCE DR |
| Manufacturer City | N MANKATO MN 56003 |
| Manufacturer Country | US |
| Manufacturer Postal | 56003 |
| Manufacturer Phone | 5073456200 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RB |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMOENA |
| Generic Name | LUXA CONTACT BREAST FORM |
| Product Code | KCZ |
| Date Received | 2000-11-03 |
| Model Number | 880-8R |
| Catalog Number | 880 |
| Lot Number | NI |
| ID Number | * |
| 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 | 293531 |
| Manufacturer | COLOPLAST CORP. |
| Manufacturer Address | 1955 WEST OAK CIRCLE MARIETTA GA 30062 US |
| Baseline Brand Name | AMOENA |
| Baseline Generic Name | EXTERNAL BREAST PROSTHESIS |
| Baseline Model No | 880-8R |
| Baseline Catalog No | 880 |
| Baseline ID | NA |
| Baseline Device Family | PROSTHESIS |
| 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. Life Threatening | 2000-11-03 |