MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-05-21 for 80 X 36 X 6 INNERSPRING MATTRESS 1633 9153647268 5185 manufactured by Invacare Florida Operations.
[5876978]
End user's daughter alleges that springs are coming up through mattress. Mother is (b)(6) and (b)(6) lbs. Weight capacity is (b)(4). Mattress is (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[13395778]
Follow up to be sent if additional information is received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1031452-2015-13866 |
| MDR Report Key | 4786986 |
| Report Source | 04 |
| Date Received | 2015-05-21 |
| Date of Report | 2015-04-27 |
| Date Mfgr Received | 2015-04-27 |
| Date Added to Maude | 2015-05-21 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KEVIN GUYTON |
| Manufacturer G1 | INVACARE FLORIDA OPERATIONS |
| Manufacturer Street | 2101 EAST LAKE MARY BLVD |
| Manufacturer City | SANFORD FL 32773 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32773 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 80 X 36 X 6 INNERSPRING MATTRESS 1633 9153647268 |
| Generic Name | CUSHION, FLOTATION |
| Product Code | FMW |
| Date Received | 2015-05-21 |
| Model Number | 5185 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVACARE FLORIDA OPERATIONS |
| Manufacturer Address | 2101 EAST LAKE MARY BLVD SANFORD FL 32773 US 32773 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-05-21 |