FDA Adverse Event
Injury
Summary report: N
SILASTIC(R) MSI MAMMARY IMPLANT, H.P. HPR
MDR report key: 41508
·
Received October 3, 1996
Report
- Report Number
- 1816403-1996-00101
- Event Type
- Injury
- Date Received
- October 3, 1996
- Date of Event
- September 3, 1996
- Report Date
- September 3, 1996
- Manufacturer
- DOW CORNING CORP
- Product Code
- FTR
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTER ALLEGES PATIENT RECEIVED IMPLANTS ON AN UNK DATE. REPORTER ALSO ALLEGES PATIETN HAD REMOVAL ON SEPT. 3, 1996 DUE TO "MECHANICALLY DEFECTIVE" IMPLANTS; HOWEVER, NO SPECIFICS WERE GIVEN. REF. MEDWATCH #1009991.
Description of Event or Problem · 1
REPORTER ALLEGES PATIENT RECEIVED IMPLATNS ON AN UNK DATE. REPORTER ALSO ALLEGES PATIENT HAD REMOVAL ON SEPT. 3, 1996 DUE TO "MECHANICALLY DEFECTIVE" IMPLANTS; HOWEVER, NO SPECIFICS WERE GIVEN. REF. MEDWATCH #1010991.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SILASTIC(R) MSI MAMMARY IMPLANT, H.P. HPR Implant | MAMMARY IMPLANT GEL-FILLED | FTR | DOW CORNING CORP | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Required Intervention |