MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-05 for ORTHO-GLASS SPLINTING SYSTEM manufactured by Bsn Medical.
[48720884]
Patient Sequence No: 1, Text Type: N, H10
[48720885]
Patient status post right femur intramedullary fixation. The patient developed an unstageable pressure ulcer. The lesion is located on the right heel and measures 3. 5cmx4 cm. Treatment has been initiated and will be monitored by the wound care team.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5768608 |
| MDR Report Key | 5768608 |
| Date Received | 2016-07-05 |
| Date of Report | 2016-06-30 |
| Date of Event | 2016-05-19 |
| Report Date | 2016-06-29 |
| Date Reported to FDA | 2016-06-29 |
| Date Reported to Mfgr | 2016-06-29 |
| Date Added to Maude | 2016-07-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORTHO-GLASS SPLINTING SYSTEM |
| Generic Name | BANDAGE, CAST |
| Product Code | ITG |
| Date Received | 2016-07-05 |
| Device Availability | N |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BSN MEDICAL |
| Manufacturer Address | 5825 CARNEGIE BLVD CHARLOTTE NC 28209 US 28209 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2016-07-05 |