MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-20 for PROAXIS PATIENT CARE KIT, NO FACE CUSHION OR ACP TUBING 6988A-PCS manufactured by Mizuho Orthopedic Systems, Inc..
[32100961]
Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[32100962]
A patient had rashes and small pressure ulcers possibly from our proaxis care kit. The pt. Was a (b)(6) male, case was 10 hours in prone position on proaxis. They used 6988a care kit. The patient had rashes/ulcer on face, chest, upper thigh, iliac crest areas. She mentioned that the care kit "had a funky dye like odor when opened the kit".
Patient Sequence No: 1, Text Type: D, B5
[54895955]
The contact has not provided further details or returned the pads or p-kits for evaluation, per our request. Further training is recommended on the patient positioning and pressure management by the sales representative. June 29, 2016 emailed they are too busy, and are having no issues at this time. Three attempts have been made to in-service and hospital staff in charge in not interested in re-training.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2921578-2015-00015 |
| MDR Report Key | 5238848 |
| Date Received | 2015-11-20 |
| Date of Report | 2016-08-15 |
| Date of Event | 2015-09-01 |
| Date Mfgr Received | 2015-09-17 |
| Date Added to Maude | 2015-11-20 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MARK DESILETS |
| Manufacturer Street | 30031 AHERN AVENUE |
| Manufacturer City | UNION CITY CA 945871234 |
| Manufacturer Country | US |
| Manufacturer Postal | 945871234 |
| Manufacturer Phone | 5104291500 |
| Manufacturer G1 | MIZUHO ORTHOPEDIC SYSTEMS, INC. |
| Manufacturer Street | 30031 AHERN AVENUE |
| Manufacturer City | UNION CITY CA 945871234 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 945871234 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROAXIS PATIENT CARE KIT, NO FACE CUSHION OR ACP TUBING |
| Generic Name | PATIENT CARE KIT |
| Product Code | KME |
| Date Received | 2015-11-20 |
| Model Number | 6988A-PCS |
| Catalog Number | 6988A-PCS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIZUHO ORTHOPEDIC SYSTEMS, INC. |
| Manufacturer Address | 30031 AHERN AVENUE UNION CITY CA 945871234 US 945871234 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-11-20 |