MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2004-09-02 for INVERNESS EAR PIERCING SYSTEM * manufactured by Inverness Corp..
[17486911]
Consumer claims to have ears pierced with the inverness system at a retail vendor in 2003. Sough medical attention for redness and swelling at the piercing site 22 days later. Oral antibiotics were prescribed at that time. Sought medical attention again the next day and an incision and drainage was performed. A new oral antibiotic was prescribed after three days.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243569-2004-00013 |
| MDR Report Key | 542281 |
| Report Source | 00 |
| Date Received | 2004-09-02 |
| Date of Report | 2004-08-30 |
| Date of Event | 2003-08-31 |
| Date Mfgr Received | 2003-10-07 |
| Date Added to Maude | 2004-09-08 |
| 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 | 2004-09-02 |
| 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 | 531654 |
| Manufacturer | INVERNESS CORP. |
| Manufacturer Address | 17-10 WILLOW STREET FAIR LAWN NJ 07410 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-09-02 |