MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2011-12-16 for MATTRESS COVER FOR MEDICAL PURPOSES 5185B manufactured by Hickory Springs Mfg. Co..
[2450920]
Dealer alleges that the mattress is breaking down. No injury is alleged.
Patient Sequence No: 1, Text Type: D, B5
[9517600]
The device reported, 5185b, is a general purpose medical mattress and is not a registered medical device. The pt's weight exceeds the distributors recommended weight limit of 250 lb.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008581949-2011-00001 |
| MDR Report Key | 2392362 |
| Report Source | 08 |
| Date Received | 2011-12-16 |
| Date of Report | 2011-12-16 |
| Date of Event | 2011-10-01 |
| Date Mfgr Received | 2011-12-01 |
| Date Added to Maude | 2012-07-26 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ROBERT AYCOCK |
| Manufacturer Street | 234 CDF BLVD PO BOX 459 |
| Manufacturer City | VERONA MS 38879 |
| Manufacturer Country | US |
| Manufacturer Postal | 38879 |
| Manufacturer Phone | 6625662322 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MATTRESS COVER FOR MEDICAL PURPOSES |
| Generic Name | 880.6190 |
| Product Code | KME |
| Date Received | 2011-12-16 |
| Model Number | 5185B |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HICKORY SPRINGS MFG. CO. |
| Manufacturer Address | VERONA MS 38879 US 38879 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-12-16 |