MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-25 for HILL ROM TEMPURPEDIC COMFORT PAD P8050 manufactured by Hill-rom, Inc.
[80926270]
Patient Sequence No: 1, Text Type: N, H10
[80926271]
Elastic band no longer functional. Causes overlay to move on mattress, even hang over the edges of the normal mattress. Training upon receipt of the affinity 4 beds: staff instructed to pull overlay over the bed frame. Elastic quickly worn out in less than 1 year, overlays replaced by hill-rom with new instruction to pull the overlay over the mattress, not the bedframe occurred. Gathering of tempurpedic material, causing a lateral lump across the lumbar area. Many patient complaints about discomfort with the overlays. Visible discoloration outlines with irregular borders on the overlay cover, despite following manufacturing cleaning guidelines. Manufacturer response for mattress overlay, hill rom tempurpedic comfort pad (per site reporter). Hill rom came out to assess the overlays and has yet to offer any explanation or assistance for this issue. We have 13 of this product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6739748 |
| MDR Report Key | 6739748 |
| Date Received | 2017-07-25 |
| Date of Report | 2017-07-19 |
| Date of Event | 2017-07-07 |
| Report Date | 2017-07-19 |
| Date Reported to FDA | 2017-07-19 |
| Date Reported to Mfgr | 2017-07-19 |
| Date Added to Maude | 2017-07-25 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | RISK MANAGER |
| 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 TEMPURPEDIC COMFORT PAD |
| Generic Name | COVER, MATTRESS (MEDICAL PURPOSES) |
| Product Code | FMW |
| Date Received | 2017-07-25 |
| Model Number | P8050 |
| Device Availability | * |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HILL-ROM, INC |
| Manufacturer Address | 1069 STATE ROUTE 46 EAST BATESVILLE IN 47006 US 47006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-25 |