MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-17 for CRAFTMATIC MODEL 1 BASE M1242-05 CMMOD1 manufactured by Craftmatic Industries, Inc..
[176611830]
Unique id (b)(4). Reached out to (b)(6) on (b)(6) 2019 at 11:37 am pacific time, the customer has not taken the pictures of the mattress yet stated that the mrs. Fell out of bed last night. Asked customer if she can sleep somewhere else in the mean time if this is an issue. Asked if they could swap beds for now, the customer has not considered that, but may now. Also discussed a bed cane, a device to assist customer staying in bed, it seems that this may be needed. The customer is busy with an appointment this week, he will take a picture next week. When additional information is available a follow up submission form will be submitted to the fda.
Patient Sequence No: 1, Text Type: N, H10
[176611831]
On (b)(6) 2019 at 1:22 pm pct, i spoke to mr. (b)(6). The customer has a queen sized bed that he and his wife both use. Claims that they raise the bed in the evening to watch tv, then they flatten the bed and there is a crease or a depression remaining from the elevation. Claims the mrs. Slid out of bed three to four times in the last couple of weeks. She was not injured and no medical assistance was sought. They have rotated the mattress, but have not flipped it. The bend is in the middle. The customer believes that the reason the mrs. Has slid out of bed is because she sleeps on her side and the dip lets her slide out, he sleeps on his back and does not slide out of bed. The mrs. Is not bed ridden and does not require assistance in getting in and out of bed, she is mobile, in her 60s and weighs about 150-160 pounds, but he is not sure. The mrs. Sleeps on her side facing the middle with her legs bent (fetal position) and her back side slides out. The mattress has become softer in the middle. I have requested pictures from customer. He is in his 80s and is on dialysis, unable to take the information down. Asked customer to have his wife call us when shew is available so i provide a delivery method for the pictures. The customer stated that he will follow up on that as soon as he can and mentioned casually that he used to work for a personal injury law firm for a few years.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008872045-2020-00001 |
| MDR Report Key | 9602518 |
| Report Source | CONSUMER |
| Date Received | 2020-01-17 |
| Date of Report | 2019-12-17 |
| Date of Event | 2019-12-17 |
| Date Mfgr Received | 2019-12-17 |
| Date Added to Maude | 2020-01-17 |
| 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 | 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 | 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 | 2020-01-17 |
| Model Number | M1242-05 |
| 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 | 2020-01-17 |