MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-05 for PONSETI MITCHELL BRACES manufactured by Md Orthopedics.
[84869219]
Patient Sequence No: 1, Text Type: N, H10
[84869223]
Newborn wearing ponseti mitchell boots (braces); staff notes wounds on right foot and today noted stage iii pressure ulcer on her left posterior ankle from the boots. Also noted was erythema also on her right toe, stage i from pressure. Wound care nurse assessed ulcers; per nurse, physician states boots need to be tight. Nurses questions if vendor should be notified as boots should not cause multiple pressure ulcers.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6842121 |
| MDR Report Key | 6842121 |
| Date Received | 2017-09-05 |
| Date of Report | 2017-08-21 |
| Date of Event | 2017-08-04 |
| Report Date | 2017-08-21 |
| Date Reported to FDA | 2017-08-21 |
| Date Reported to Mfgr | 2017-08-21 |
| Date Added to Maude | 2017-09-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PONSETI MITCHELL BRACES |
| Generic Name | ORTHOSIS, CORRECTIVE SHOE |
| Product Code | KNP |
| Date Received | 2017-09-05 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MD ORTHOPEDICS |
| Manufacturer Address | 604 NORTH PARKWAY ST WAYLAND IA 52654 US 52654 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-09-05 |