MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-29 for HILL-ROM PROGRESS SPECIALLY BED MATTRESS COVERLETS manufactured by Hill-rom, Inc..
[143609872]
Safety concern related to lack of proper cleaning and disinfection (i. E. , stains and odor). The mfr recommendations included surface cleaning and disinfection of coverlets, versus traditional coverlet removal and laundering after each pt. Coverlets have not been removed from mattresses since purchase. Upon further inspection of pad and mattress beneath coverlets, staining, crusting, and foul odor were identified. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086257 |
| MDR Report Key | 8565057 |
| Date Received | 2019-04-29 |
| Date of Report | 2019-04-25 |
| Date of Event | 2019-04-19 |
| Date Added to Maude | 2019-04-30 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | HILL-ROM PROGRESS SPECIALLY BED MATTRESS COVERLETS |
| Generic Name | COVER, MATTRESS |
| Product Code | FMW |
| Date Received | 2019-04-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HILL-ROM, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-29 |