MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-10-24 for AMOENA 880-8R STYLE 061 manufactured by Coloplast.
[17491131]
Rptr started having chills. Went to bed and woke up feeling terrible. Child came at 3 and noticed rptr had a bad red rash on chest where breast was removed. Called the dr and it took up to about an hr to get there. The nurse met rptr and sent rptr directly to er. Rptr was admitted to hosp and was diagnosed with cellulitis. This caused rptr to go into septic shock. Rptr thinks the amoena prosthesis caused problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1020298 |
| MDR Report Key | 302753 |
| Date Received | 2000-10-24 |
| Date of Report | 2000-10-23 |
| Date of Event | 2000-01-11 |
| Date Added to Maude | 2000-11-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMOENA |
| Generic Name | SELF-ADHESIVE EXTERNAL |
| Product Code | KCZ |
| Date Received | 2000-10-24 |
| Model Number | 880-8R |
| Catalog Number | STYLE 061 |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 293035 |
| Manufacturer | COLOPLAST |
| Manufacturer Address | 1955 WEST OAK CIRCLE MARIETTA GA 300622249 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening | 2000-10-24 |