MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-15 for EXTERNAL FIXATOR DEVICE UNK UNKNOWN manufactured by Unk.
[19762186]
Patient turned to the left side during chlorhexidine bath. External fixator device caused a gash in the medial aspect of left leg. Ccm aware and has viewed the skin alteration. Ccm states they will notify ortho. Charge nurse notified. Awaiting further orders from ccm or ortho.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4284204 |
| MDR Report Key | 4284204 |
| Date Received | 2014-09-15 |
| Date of Report | 2014-09-15 |
| Date of Event | 2014-09-12 |
| Report Date | 2014-09-15 |
| Date Reported to FDA | 2014-09-15 |
| Date Reported to Mfgr | 2014-11-28 |
| Date Added to Maude | 2014-11-28 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXTERNAL FIXATOR DEVICE |
| Generic Name | SYSTEM, EXTERNAL FIXATOR (WITH METALLIC INVASIVE COMPONENTS) |
| Product Code | NDK |
| Date Received | 2014-09-15 |
| Model Number | UNK |
| Catalog Number | UNKNOWN |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2014-09-15 |