MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2006-12-06 for INVERNESS EAR PIERCING SYSTEM * manufactured by Inverness Corp..
[543145]
Consumer claims to have had ears pierced with the inverness system at a retail vendor in 2006. Sought medical attention for redness and swelling at the piercing site two months later and an oral antibiotic was prescribed. A month later returned for medical attention, at that time an incision and drainage was performed and she was prescribed a new oral antibiotic.
Patient Sequence No: 1, Text Type: D, B5
[7913972]
Incident reported to inverness on 6/29/06. Requested add'l info on 6/29/06 and 7/14/06. Add'l info was not rec'd until 10/27/06. Earrings not returned to mfr for eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243569-2006-00009 |
| MDR Report Key | 792665 |
| Report Source | 04 |
| Date Received | 2006-12-06 |
| Date of Report | 2006-11-15 |
| Date of Event | 2006-03-07 |
| Date Mfgr Received | 2006-06-29 |
| Date Added to Maude | 2006-12-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | HELENE BERNSTEIN |
| Manufacturer Street | 17-10 WILLOW STREET |
| Manufacturer City | FAIR LAWN NJ 07410 |
| Manufacturer Country | US |
| Manufacturer Postal | 07410 |
| Manufacturer Phone | 2017943400 |
| Manufacturer G1 | INVERNESS CORPORATION |
| Manufacturer Street | 17-10 WILLOW STREET |
| Manufacturer City | FAIR LAWN NJ 07410 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07410 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INVERNESS EAR PIERCING SYSTEM |
| Generic Name | EAR PIERCING INSTRUMENT AND EAR PIERCING EARRINGS |
| Product Code | JYS |
| Date Received | 2006-12-06 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 780305 |
| Manufacturer | INVERNESS CORP. |
| Manufacturer Address | 17-10 WILLOW ST. FAIR LAWN NJ 07410 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-12-06 |