MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-17 for UPPER MODULE, COM1 BRZ-CG1-CUD-110 201665 manufactured by Allergan (pleasanton).
| Report Number | 3007215625-2020-00021 |
| MDR Report Key | 9838948 |
| Report Source | CONSUMER |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-16 |
| Date Mfgr Received | 2019-10-29 |
| Date Added to Maude | 2020-03-17 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JENNIFER CLETO |
| Manufacturer Street | 4410 ROSEWOOD DRIVE |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal | 94588 |
| Manufacturer Phone | 9256214130 |
| Manufacturer G1 | ALLERGAN (PLEASANTON) |
| Manufacturer Street | 4410 ROSEWOOD DRIVE |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94588 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UPPER MODULE, COM1 |
| Generic Name | DERMAL COOLING PACK/VACUUM/MASSAGER |
| Product Code | OOK |
| Date Received | 2020-03-17 |
| Model Number | BRZ-CG1-CUD-110 |
| Catalog Number | 201665 |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLERGAN (PLEASANTON) |
| Manufacturer Address | 4410 ROSEWOOD DRIVE PLEASANTON CA 94588 US 94588 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-17 |