MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-08 for COOLSCULPTING manufactured by Allergan / Zeltiq Aesthetics Inc..
[141505851]
During the month of (b)(6) in 2018, i had 12 sessions of coolsculpting on my upper / lower abdomen and right / left flanks. Immediately after the procedure, i had massive swelling and nerve pain. These symptoms stopped around one month after the procedure. In (b)(6), i went for a f/u appt, i had pictures taken of my progress. I had a reduction in the areas that were coolsculpt. However, in the following months, i started to experience fat growth in the areas treated by the procedure. It was very noticeable. The areas treated tripled in size with noticeable fat. I contacted the office where i had the procedure and went in for another f/u. They took pictures and sent all of my info to the company reportable for the equipment. I never heard anything back. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085667 |
| MDR Report Key | 8496484 |
| Date Received | 2019-04-08 |
| Date of Report | 2019-04-04 |
| Date of Event | 2018-01-18 |
| Date Added to Maude | 2019-04-09 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COOLSCULPTING |
| Generic Name | DERMAL COOLING PACK / VACUUM MASSAGER |
| Product Code | OOK |
| Date Received | 2019-04-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLERGAN / ZELTIQ AESTHETICS INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-08 |