MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2007-05-22 for INVERNESS EAR PIERCING SYSTEM manufactured by Inverness Corp..
[15486777]
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.
Patient Sequence No: 1, Text Type: D, B5
[15591550]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243569-2007-00001 |
| MDR Report Key | 854689 |
| Report Source | 00 |
| Date Received | 2007-05-22 |
| Date of Report | 2007-05-08 |
| Date of Event | 2005-09-12 |
| Date Mfgr Received | 2006-07-27 |
| Date Added to Maude | 2008-02-28 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | HERLENE 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 CORP. |
| Manufacturer Street | 1710 WILLOW ST. |
| 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 |
| Product Code | JYS |
| Date Received | 2007-05-22 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 961670 |
| Manufacturer | INVERNESS CORP. |
| Manufacturer Address | FAIR LAWN NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-05-22 |