MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2006-12-21 for INVERNESS EAR PIERCING SYSTEM * manufactured by Inverness Corp..
[21992458]
Received claim on 04/10/06. Requested add'l info on 05/02/06 and 05/17/06. Did not receive info until 11/22/06. Earrings were not returned to mfr for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[22187524]
Consumer claims to have had ears pierced at a retail vendor with the inverness system in 2006. Sought medical attention for redness and swelling at the piercing site about 2 weeks later. An incision and drainage was performed and an oral antibiotic was prescribed at that time. Sought medical attention again the next day and was admitted to the hospital at that time and i. V. Antibiotics were administered. She was discharged 3 days later. Three days later, she sought medical attention and was admitted to the hospital again for i. V. Antibiotics and discharged 6 days later with oral antibiotics prescribed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243569-2006-00010 |
| MDR Report Key | 799473 |
| Report Source | 00 |
| Date Received | 2006-12-21 |
| Date of Report | 2006-12-14 |
| Date of Event | 2006-03-20 |
| Date Mfgr Received | 2006-04-10 |
| Date Added to Maude | 2007-01-03 |
| 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 | HELENE 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 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 |
| Product Code | JYS |
| Date Received | 2006-12-21 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 786991 |
| Manufacturer | INVERNESS CORP. |
| Manufacturer Address | * FAIR LAWN NJ * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-12-21 |