MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-06-14 for JAY 2 CUSHION MF2105I manufactured by Sunrise Medical Technolgias.
[3472747]
Per sunrise medical affiliate in (b)(4), (b)(6), end user has developed decubitus ulcers in the coccyx region.
Patient Sequence No: 1, Text Type: D, B5
[10852520]
The product hasn't been returned to the mfr for evaluation due to the product being scrapped by the end user. An investigation of this particular incident can't be performed at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616084-2013-00002 |
| MDR Report Key | 3177311 |
| Report Source | 07 |
| Date Received | 2013-06-14 |
| Date of Report | 2013-05-14 |
| Date of Event | 2013-05-14 |
| Date Mfgr Received | 2013-05-14 |
| Date Added to Maude | 2013-06-20 |
| 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, RA/QA SPECIALIST |
| Manufacturer Street | 2842 BUSINESS PARK AVE |
| Manufacturer City | FRESNO CA 93727 |
| Manufacturer Country | US |
| Manufacturer Postal | 93727 |
| Manufacturer Phone | 5592942840 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JAY 2 CUSHION |
| Generic Name | JAY COUSHION |
| Product Code | IMP |
| Date Received | 2013-06-14 |
| Model Number | MF2105I |
| 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 TECHNOLGIAS |
| Manufacturer Address | PRIVADA MISIONS #110 PARGUE INDUCATRIAL MISIONES TIJUANA, B.C. 22425 MX 22425 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-06-14 |