MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-30 for CRAFTMATIC MODEL 1 BASE 4AR794 CMMOD1 manufactured by Craftmatic Industries, Inc..
| Report Number | 3008872045-2020-00002 |
| MDR Report Key | 9650028 |
| Report Source | CONSUMER |
| Date Received | 2020-01-30 |
| Date of Report | 2020-01-30 |
| Date of Event | 2019-11-21 |
| Date Mfgr Received | 2019-11-21 |
| Date Added to Maude | 2020-01-30 |
| 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 | 3 |
| Manufacturer Contact | MS. JESSICA VIVAR |
| Manufacturer Street | 5192 SW 27TH AVE |
| Manufacturer City | FT. LAUDERDALE FL 33312 |
| Manufacturer Country | US |
| Manufacturer Postal | 33312 |
| Manufacturer Phone | 9548280893 |
| Manufacturer G1 | CRAFTMATIC INDUSTRIES, INC. |
| Manufacturer Street | 3580 GATEWAY DR |
| Manufacturer City | POMPANO BEACH FL 33069 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33069 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRAFTMATIC MODEL 1 BASE |
| Generic Name | BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE |
| Product Code | LLI |
| Date Received | 2020-01-30 |
| Model Number | 4AR794 |
| Catalog Number | CMMOD1 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRAFTMATIC INDUSTRIES, INC. |
| Manufacturer Address | 3580 GATEWAY DR POMPANO BEACH FL 33069 US 33069 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-30 |