FDA Adverse Event
Other
Summary report: N
INVERNESS EAR PIERCING SYSTEM
MDR report key: 285851
·
Received July 14, 2000
Report
- Report Number
- 2243569-2000-00033
- Event Type
- Other
- Date Received
- July 14, 2000
- Date of Event
- June 27, 2000
- Report Date
- July 14, 2000
- Manufacturer
- INVERNESS CORP.
- Product Code
- JYS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CONSUMER CLAIMS TO HAVE BEEN PIERCED WITH THE INVERNESS EAR PIERCING SYSTEM AT A RETAIL VENDOR IN 2000. ONE EARRING EMBEDDED IN THE LOBE. CONSUMER SOUGHT MEDICAL TREATMENT 16 DAYS LATER; THE EARRING WAS REMOVED AND ANTIBIOTICS WERE PRESCRIBED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INVERNESS EAR PIERCING SYSTEM | EAR PIERCING INSTRUMENT AND EAR PIERCING EARRINGS | JYS | INVERNESS CORP. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |