MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2005-02-16 for INVERNESS EAR PIERCING SYSTEM * manufactured by Inverness Corporation.
[20919978]
Consumer claims to have had ears pierced with the inverness system at a retail vendor in 03. Sought medical attention for redness and swelling at the piercing site 10 days later and an oral antibiotic was prescribed. They refused an incision and drainage at the time. Returned for medical treatment the following day and an incision and drainage was performed. They were admitted into the hospital 9 days later and an incision and drainage was performed and i. V. Antibiotics were administered. They were discharged the next day. Another incision and drainage was performed 7 days later. They received i. V. Antibiotics to be administered at home and were continued on oral antibiotics.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243569-2005-00004 |
| MDR Report Key | 574572 |
| Report Source | 00 |
| Date Received | 2005-02-16 |
| Date of Report | 2005-02-11 |
| Date of Event | 2003-04-19 |
| Date Mfgr Received | 2004-03-18 |
| Date Added to Maude | 2005-02-23 |
| 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 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 | 2005-02-16 |
| 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 | 564420 |
| Manufacturer | INVERNESS CORPORATION |
| Manufacturer Address | 17-10 WILLOW STREET FAIR LAWN NJ 07410 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-02-16 |