MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2015-06-13 for MATTRESS THERAPY 42 X 84 X 6.5 9153651287 IES0080 manufactured by Invacare (ltd) Uk.
[6010325]
The provider states the mattress is bottoming out. The provider states there were no injuries.
Patient Sequence No: 1, Text Type: D, B5
[14030783]
A returned was issued and the product was evaluated upon receipt. The mattress was sagging.
Patient Sequence No: 1, Text Type: N, H10
[19505369]
The provider states the mattress is bottoming out. The provider states there were no injuries.
Patient Sequence No: 1, Text Type: D, B5
[19623393]
A returned was issued and the product is awaiting receipt and/or evaluation. A follow up will be filed if/when any additional information is provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007582653-2015-00006 |
| MDR Report Key | 4842791 |
| Report Source | 08 |
| Date Received | 2015-06-13 |
| Date of Report | 2015-05-20 |
| Date Mfgr Received | 2015-05-20 |
| Date Added to Maude | 2015-07-10 |
| 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 | MATTRESS THERAPY 42 X 84 X 6.5 9153651287 |
| Generic Name | MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE |
| Product Code | KIC |
| Date Received | 2015-06-13 |
| Returned To Mfg | 2015-06-23 |
| Model Number | IES0080 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2015-06-13 |