MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-10-09 for JAY UNION CUSHION BJU2119 manufactured by Sunrise Medical.
[3780055]
A dealer called sunrise medical on (b)(6) 2013 to report an adverse event. The dealer reported that the jay union cushion has slowly flattened out. The dealer is alleging that this has caused the end user to developed a stage 2 pressure sore near his upper thigh area.
Patient Sequence No: 1, Text Type: D, B5
[11118646]
Sunrise medical sent a replacement cushion to the end user on (b)(6) 2013. The new cushion should prevent the sores from worsening or recurring. The old cushion is being returned for investigation. If and when the cushion is received, our internal failure investigator will complete the investigation and a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616084-2013-00005 |
| MDR Report Key | 3415397 |
| Report Source | 07 |
| Date Received | 2013-10-09 |
| Date of Report | 2013-09-26 |
| Date of Event | 2013-09-26 |
| Date Mfgr Received | 2013-09-26 |
| Date Added to Maude | 2013-10-18 |
| 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 | JEREMY YBARRA |
| Manufacturer Street | 2842 BUSINESS PARK AVENUE |
| Manufacturer City | FRESNO CA 93727 |
| Manufacturer Country | US |
| Manufacturer Postal | 93727 |
| Manufacturer Phone | 5582842749 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JAY UNION CUSHION |
| Generic Name | JAY CUSHION |
| Product Code | IMP |
| Date Received | 2013-10-09 |
| Model Number | BJU2119 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUNRISE MEDICAL |
| Manufacturer Address | PRIVADA MISIONS #110 PARGUE INDUCATRIAL MISIONES TIJUANA BAJA CA 22425 US 22425 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-10-09 |