MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-22 for COSMETIC, DIETARY SUPPLEMENT OR FOOD/MEDICINAL FOOD manufactured by Allergan India Ltd / Zeltiq Aesthetics Inc..
| Report Number | MW5091278 |
| MDR Report Key | 9369087 |
| Date Received | 2019-11-22 |
| Date of Report | 2019-11-21 |
| Date of Event | 2019-04-30 |
| Date Added to Maude | 2019-11-25 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COSMETIC, DIETARY SUPPLEMENT OR FOOD/MEDICINAL FOOD |
| Generic Name | DERMAL COOLING PACK / VACUUM / MASSAGER |
| Product Code | OOK |
| Date Received | 2019-11-22 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLERGAN INDIA LTD / ZELTIQ AESTHETICS INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-22 |