MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-01-12 for BOVINE COLLAGEN RADIOPAQUE * manufactured by Ethicon-endo - Johnson And Johnson Subsection_ In Ohio/or Imported.
[552987]
In 2006 i had a stereotactic needle core biopsy. At no time did dr physically examine or discuss with me the procedure or the implantation of a bovine collagen radiopaque to which i had an adverse allergic reaction. This means that after the huge hematoma blew out of the infected incision in the shower, i went to get treatment at the local hospital. The bovine collagen radiopaque wiggled its way out of the large hole in my breast onto a piece of gauze. I took the radiopaque to the family doctor who sent it to a pathology lab. I never consented to be injected with the radiopaque or was in any way informed of adverse allergic reactions. I experienced incredible pain and anguish because my breast looked like i was shot with a 44 caliber bullet with pus and blood oozing out of the wound. A few days ago i underwent emergency surgery on the breast to clean out the abscess/infection. Ethicon surgical products is the manufacturer of the radiopaque and i was told that never had a radiopaque been ejected since it was first used in 1998.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1041632 |
| MDR Report Key | 805198 |
| Date Received | 2007-01-12 |
| Date of Report | 2007-01-12 |
| Date of Event | 2006-12-04 |
| Date Added to Maude | 2007-01-18 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BOVINE COLLAGEN RADIOPAQUE |
| Generic Name | CHIP, CLIP, TAG, OR MARKER |
| Product Code | LMI |
| Date Received | 2007-01-12 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 792709 |
| Manufacturer | ETHICON-ENDO - JOHNSON AND JOHNSON SUBSECTION_ IN OHIO/OR IMPORTED |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2007-01-12 |