MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-02-02 for IGIA FINALLY GONE HAIR REMOVAL SYSTEM AT6758 * manufactured by Tactica International.
[461435]
Pt was born with caudal regression syndrome which is a deformity in the lower spine where her sacrum and tail bone did not develop. Because of this deformity, her nerves in her lower body may be affected. This caused her to have bilateral club feet which have been casted for the last couple months and may require surgery. Her ability to walk is unknown at this time. In addition, this syndrome can cause proplems with her urinary tract and bowel movements. The majority of her problems will not be known until she gets a little older. She has reflux of urine from her bladder back into her kidneys. She is on a low dose of amoxicillin to prevent any bladder or kidney infections. In addition to the caudal regression, she has a moderate hearing loss in her right ear which will require a hearing aid, she is missing one rib, and had a small hole in her heart. Caudal regression syndrome and these other deformities are not caused by genetics and doctors do not know the cause. Since the ear drums, organs and spinal cord are formed during the first couple months of gestation, i can not help but wonder if some of her problems are related to me using the igia finally gone product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1038159 |
| MDR Report Key | 686240 |
| Date Received | 2005-02-02 |
| Date of Report | 2005-02-02 |
| Date of Event | 2004-09-28 |
| Date Added to Maude | 2006-03-15 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IGIA FINALLY GONE HAIR REMOVAL SYSTEM |
| Generic Name | PERMANENT HAIR REMOVAL |
| Product Code | KCX |
| Date Received | 2005-02-02 |
| Model Number | AT6758 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 675465 |
| Manufacturer | TACTICA INTERNATIONAL |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Congenital Not Applicablenomaly; 2. Required No Informationntervention; 3. Deathisabilit | 2005-02-02 |