MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-06 for JOBST CUSTOM FIT GRADUATED COMP STOCKING VELCRO GARTER BELT 111354 AND SOFT ENCLOSED TOE- manufactured by Jobst Institute.
[12019]
Resident developed multiple pressure sores on his feet requiring skin ulceration treatments, physician assessement and antibiotic therapy. 4 of the sores were open and one was closed pressure area. This occurred approximately 10-14 days after applying custom fit graduated compression stockings for edema in the lower extremities.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 16221 |
| MDR Report Key | 16221 |
| Date Received | 1994-07-06 |
| Date of Report | 1993-12-17 |
| Date of Event | 1993-12-07 |
| Date Facility Aware | 1993-12-07 |
| Report Date | 1993-12-17 |
| Date Reported to Mfgr | 1993-12-17 |
| Date Added to Maude | 1994-09-19 |
| 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 | JOBST CUSTOM FIT GRADUATED COMP STOCKING VELCRO GARTER BELT |
| Generic Name | LENGTH SUPPORT WITH SOFT ENCLOSED TOE |
| Product Code | LLK |
| Date Received | 1994-07-06 |
| Model Number | GARTER BELT |
| Catalog Number | 111354 AND SOFT ENCLOSED TOE- |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 14 DAY |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 16154 |
| Manufacturer | JOBST INSTITUTE |
| Manufacturer Address | 653 MIAMI STREET TOLEDO OH 43605 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-07-06 |