MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 1999-06-22 for INVERNESS EAR PIERCING SYSTEM * manufactured by Inverness Corp..
[126517]
Consumer claims to have been pierced with the inverness ear piercing system on 3/17/99. A few days later her ear was getting red so she tried to remove the earring causing it to become embedded in her ear. She sought medical treatment for removal and was prescribed an antibiotic.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243569-1999-00028 |
| MDR Report Key | 229679 |
| Report Source | 04 |
| Date Received | 1999-06-22 |
| Date of Report | 1999-06-22 |
| Date of Event | 1999-03-17 |
| Date Mfgr Received | 1999-06-14 |
| Date Added to Maude | 1999-07-02 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| 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 | JXS |
| Date Received | 1999-06-22 |
| Model Number | * |
| 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 | 222749 |
| Manufacturer | INVERNESS CORP. |
| Manufacturer Address | 17-10 WILLOW ST. FAIR LAWN NJ 07410 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-06-22 |