MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2015-06-05 for FOAM MATTRESS VINYL 9153633137 IES0080 manufactured by Invacare (ltd) Uk.
[5838459]
Provider states that all three mattresses cratered in the middle. No additional information provided and protocol questions do not apply. Information found in oracle: provider states that all three mattresses cratered in the middle. Date codes on two of the mattress are (b)(6) 2015 and the other one is (b)(6) 2015. Advised law label only.
Patient Sequence No: 1, Text Type: D, B5
[13344665]
A follow up will be sent if the product or additional information is obtained.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007582653-2015-00002 |
| MDR Report Key | 4821777 |
| Report Source | 08 |
| Date Received | 2015-06-05 |
| Date of Report | 2015-05-08 |
| Date Mfgr Received | 2015-05-08 |
| Date Added to Maude | 2015-07-06 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KEVIN GUYTON |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44035 |
| Manufacturer Country | US |
| Manufacturer Postal | 44035 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | INVACARE (LTD) UK |
| Manufacturer Street | PENCOED TECHNOLOGY PARK PENCOED |
| Manufacturer City | BRIDGEND |
| Manufacturer Country | UK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FOAM MATTRESS VINYL 9153633137 |
| Generic Name | CUSHION, FLOTATION |
| Product Code | KIC |
| Date Received | 2015-06-05 |
| Model Number | IES0080 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVACARE (LTD) UK |
| Manufacturer Address | PENCOED TECHNOLOGY PARK PENCOED BRIDGEND UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-06-05 |