FDA Adverse Event
Other
Summary report: N
INVERNESS EAR PIERCING SYSTEM
MDR report key: 951538
·
Received November 15, 2007
Report
- Report Number
- 2243569-2007-00005
- Event Type
- Other
- Date Received
- November 15, 2007
- Date of Event
- December 31, 2005
- Report Date
- November 14, 2007
- Manufacturer
- INVERNESS CORPORATION
- Product Code
- JYS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INCIDENT REPORTED TO INVERNESS ON 2/6/2006. REQUESTED INFORMATION ON 9/25/2006 AND 10/10/2006 AND 7/27/2007. INFORMATION NOT RECEIVED UNTIL 10/19/2007. EARRING WERE NOT RETURNED TO MANUFACTURER FOR EVALUATION.
Description of Event or Problem · 1
CONSUMER CLAIMS TO HAVE HAD EARS PIERCED AT A RETAIL VENDOR WITH THE INVERNESS SYSTEM IN 2005. SOUGHT MEDICAL ATTENTION FOR REDNESS AND SWELLING ABOUT 5 DAYS AFTER. AN ORAL ANTIBIOTIC WAS PRESCRIBED AT THAT TIME. SOUGHT MEDICAL ATTENTION AGAIN FIVE DAYS LATER. AN ORAL ANTIBIOTIC WAS PRESCRIBED AT THAT TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INVERNESS EAR PIERCING SYSTEM | EAR PIERCING INSTRUMENT | JYS | INVERNESS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Other |