FDA Adverse Event
Injury
Summary report: N
MENTOR WORLDWIDE LLC
MDR report key: 2069661
·
Received April 14, 2011
Report
- Report Number
- 1645337-2011-00011
- Event Type
- Injury
- Date Received
- April 14, 2011
- Date of Event
- March 7, 2011
- Report Date
- April 12, 2011
- Manufacturer
- MENTOR WORLDWIDE LLC
- Product Code
- FWM
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
COMPLAINT NOTE: DIZZY, STERILE ABSCESS, TACHYCARDIA. PCP THINKS, PT HAS AN IMPLANT ALLERGY. PT WAS SEEN BY DR HADEN ON (B)(6) 2011 FOR POSSIBLE SKIN ALLERGIES AROUND BOTH BREASTS (PRIMARILY ON LEFT SIDE, BUT MINIMAL ALLERGY ON RIGHT) AND WOUND DEHISCENCE. DR (B)(4) DOESN'T KNOW IF THE ALLERGY HAS ANYTHING TO DO WITH THE IMPLANTS. THERE IS NO EVIDENCE OF IMPLANT RUPTURE. DR HADEN WILL BE DOING THE ALLERGY TESTING ON (B)(6) 2011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MENTOR WORLDWIDE LLC | SALINE-FILLED MAMMARY PROSTHESES | FWM | MENTOR WORLDWIDE LLC | 6404012 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Other |