MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2007-07-25 for INVERNESS EAR PIERCING SYSTEM manufactured by Inverness Corporation.
[17492301]
Consumer claims to have had her ears pierced with the inverness system at a retail vendor in 2002. Sought medical treatment eight days later, for redness and swelling at the piercing site and an oral antibiotic was prescribed. Sought medical attention again six days later, the next month and was admitted into hospital. During her stay, she received antibiotics and an incision and drainage was performed. She was discharged from the hospital five days later and was prescribed an oral antibiotic.
Patient Sequence No: 1, Text Type: D, B5
[17640758]
Incident reported to inverness on 05/09/2007. Requested information on 05/10/2007 and 05/25/2007. Did not receive information until 06/11/2007. Earrings were not returned to manufacturer for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243569-2007-00004 |
| MDR Report Key | 885825 |
| Report Source | 00 |
| Date Received | 2007-07-25 |
| Date of Report | 2007-07-09 |
| Date of Event | 2002-10-21 |
| Date Mfgr Received | 2007-05-09 |
| Date Added to Maude | 2007-09-25 |
| 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 | HELENE BERNSTEIN |
| Manufacturer Street | 1710 WILLOW STREET |
| Manufacturer City | FAIR LAWN NJ 07410 |
| Manufacturer Country | US |
| Manufacturer Postal | 07410 |
| Manufacturer Phone | 2017943400 |
| Manufacturer G1 | INVERNESS CORPORATION |
| Manufacturer Street | 1710 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 |
| Product Code | JYS |
| Date Received | 2007-07-25 |
| 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 | 883246 |
| Manufacturer | INVERNESS CORPORATION |
| Manufacturer Address | FAIR LAWN NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-07-25 |