MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2004-01-02 for INVERNESS EAR PIERCING SYSTEM * manufactured by Inverness Corp..
[342107]
Consumer claims to have had ear piereced with the inverness system at a retail vendor in 2001. Sought medical attention for redness and swelling at the piercing site in 11/01. An oral antibiotic was prescribed at that time. Returned for treatment in 12/01 and an incision and drainage was performed and a new oral antibiotic was prescribed. Patient returned for incision and drainage five times and was prescribed a new oral antibiotic.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243569-2003-00020 |
| MDR Report Key | 504511 |
| Report Source | 00 |
| Date Received | 2004-01-02 |
| Date of Report | 2003-12-30 |
| Date of Event | 2001-05-29 |
| Date Mfgr Received | 2003-08-15 |
| Date Added to Maude | 2004-01-07 |
| 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 | JILL TYLICKI |
| Manufacturer Street | 17-10 WILLOW STREET |
| Manufacturer City | FAIR LAWN NJ 07410 |
| Manufacturer Country | US |
| Manufacturer Postal | 07410 |
| Manufacturer Phone | 2017943400 |
| Manufacturer G1 | INVERNESS CORP. |
| 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 | 2004-01-02 |
| Model Number | NA |
| 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 | 493327 |
| Manufacturer | INVERNESS CORP. |
| Manufacturer Address | 17-10 WILLOW ST. FAIR LAWN NJ 07410 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-01-02 |