MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-01-24 for NATURAL WEAR BREAST FORMS #509 * manufactured by Camp International Inc..
[41996]
After mastectomy device was prescried by dr. Device was bought 8/20/94. Device has been used exactly according to co spc's and after 2yrs, 3 1/2 months. The skin on the inside of device split from the tight side. To past the nipple. User feels this device should be replaced by co.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1010606 |
| MDR Report Key | 64587 |
| Date Received | 1997-01-24 |
| Date of Report | 1997-01-14 |
| Date of Event | 1996-12-06 |
| Date Added to Maude | 1997-01-28 |
| 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 | NATURAL WEAR BREAST FORMS |
| Generic Name | EXTERNAL BREAST PROSTHESIS |
| Product Code | KCZ |
| Date Received | 1997-01-24 |
| Model Number | #509 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Expiration Date | 1996-08-20 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 64710 |
| Manufacturer | CAMP INTERNATIONAL INC. |
| Manufacturer Address | PO BOX 88 JACKSON MI 492040089 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-01-24 |