FDA Adverse Event
Other
Summary report: N
INVERNESS EAR PIERCING SYSTEM
MDR report key: 499816
·
Received December 5, 2003
Report
- Report Number
- 2243569-2003-00018
- Event Type
- Other
- Date Received
- December 5, 2003
- Date of Event
- March 27, 2003
- Report Date
- December 3, 2003
- 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 HAD EARS PIERCED WITH THE INVERNESS SYSTEM AT A RETAIL VENDOR. SOUGHT MEDICAL ATTENTION FOR REDNESS AND SWELLING AT THE PIERCING SITE 16 DAYS LATER, AND WAS PRESCRIBED ORAL ANTIBIOTICS. SOUGHT TREATMENT 2 DAYS LATER, AND WAS ADMITTED TO THE HOSPITAL AT THAT TIME. I.V. ANTIBIOTICS WERE ADMINISTERED DURING THEIR STAY. AN INCISION AND DRAINAGE WAS PERFORMED AND PT WAS RELEASED FROM THE HOSPITAL.
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. | NA | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Other |