MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-14 for CRAFTMATIC MODEL 1 BASE 4AR790 CMMOD1 manufactured by Craftmatic Industries, Inc..
[188690723]
Unique id (b)(4). I advised the customer how to safely get in and out of the bed. I explained that the movement of the base was caused by forcefully entering and exiting the bed while on caster wheels that were in caster cups, i explained that because his daughter removed the caster wheels from the legs; having the legs in the caster cups should prevent any movement on their hardwood floors going forward.
Patient Sequence No: 1, Text Type: N, H10
[188690724]
Customer states on (b)(6) 2019, he was getting out of bed to go to his walker and when he pushed off the bed, the motion forced the bed to back away from him which caused him to fall on the floor. The customer confirms the caster wheels were locked and the legs were in the rubber caster cups at that time. The customer states that the first time he fell, he was transferring from his wheelchair to get into bed, he plopped on the bed and the bed moved. He called the firehouse, for assistance to get off of the floor. He weighs about (b)(6) pounds. The customer does not have the assistance of a caregiver to get in and out of the bed, he lives alone. The customer states that he purchased a craftmatic bed because he had a hospital bed that he did not like. The customer states the bed is one hardwood floor. The customer states he did not sustain any injuries from the falls. The customer confirms that his daughter has removed the wheels from the bed yesterday and only has the base legs inside a caster cup presently.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008872045-2020-00003 |
| MDR Report Key | 9832961 |
| Report Source | CONSUMER |
| Date Received | 2020-03-14 |
| Date of Report | 2020-03-09 |
| Date of Event | 2019-10-21 |
| Date Mfgr Received | 2019-10-21 |
| Date Added to Maude | 2020-03-14 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 82808933 |
| Manufacturer G1 | CRAFTMATIC INDUSTRIES, INC. |
| Manufacturer Street | 3580 GATEWAY DR |
| Manufacturer City | POMPANO BEACH, FL |
| Manufacturer Country | US |
| Single Use | 3 |
| Remedial Action | NO |
| 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 | 2020-03-14 |
| Model Number | 4AR790 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-14 |