FDA Adverse Event
Other
Summary report: N
INVERNESS EAR PIERCING SYSTEM
MDR report key: 854689
·
Received May 22, 2007
Report
- Report Number
- 2243569-2007-00001
- Event Type
- Other
- Date Received
- May 22, 2007
- Date of Event
- September 12, 2005
- Report Date
- May 8, 2007
- Manufacturer
- INVERNESS CORP.
- Product Code
- JYS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INCIDENT REPORTED TO INVERNESS ON 7/27/2006. REQUESTED INFO ON 8/10/2006 AND 8/25/2006. INFO NOT RECEIVED UNTIL 4/13/2007.
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 AT THE PIERCING SITE IN 2006. AN ORAL ANTIBIOTIC WAS PRESCRIBED AT THAT TIME. SOUGHT MEDICAL ATTENTION AGAIN ONE DAY LATER THE NEXT MONTH AND AN INCISION AND DRAINAGE WAS PERFORMED AS AN OUTPATIENT PROCEDURE. CONTINUED TAKING SAME ORAL ANTIBIOTIC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INVERNESS EAR PIERCING SYSTEM | EAR PIERCING INSTRUMENT | JYS | INVERNESS CORP. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Other |