MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-02-05 for CLF2800 CLINIFLOAT * manufactured by Gaymer Industries, Inc..
[42611]
A male pt, age 72 yrs, with multiple sclerosis, having multiple stage 4 pressure ulcers, and severely contracted lower limbs, was observed with an additional injury after one day on a water floatation bed system. The injury was described as 1-1/2 diameter blister and reddened area on the left hip. The hosp personnel stated that the bed indicated an operating temp of 89 f. The pt was removed from the bed. The hosp considers the injury serious due to the pt's condition and the size of the injury. The cause of the injury has not been determined.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1313850-1997-00003 |
| MDR Report Key | 67610 |
| Report Source | 05,06 |
| Date Received | 1997-02-05 |
| Date of Report | 1997-02-04 |
| Date of Event | 1997-01-13 |
| Date Mfgr Received | 1997-01-13 |
| Device Manufacturer Date | 1996-09-01 |
| Date Added to Maude | 1997-02-11 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLF2800 CLINIFLOAT |
| Generic Name | CLINIFLOAT FLOATATION BED |
| Product Code | FOH |
| Date Received | 1997-02-05 |
| Model Number | CLF2800 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | MDR INVESTIGATED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 67628 |
| Manufacturer | GAYMER INDUSTRIES, INC. |
| Manufacturer Address | 10 CENTRE DR ORCHARD PARK NY 14127 US |
| Baseline Brand Name | CLF2800 CLINIFLOAT |
| Baseline Generic Name | CLINIFLOAT FLOTATION BED |
| Baseline Model No | CLF2800 |
| Baseline Catalog No | CLF2800 |
| Baseline ID | * |
| Baseline Device Family | FLOTATION THERAPY |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K882229 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-02-05 |