MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-12-17 for JOSCT CUSTOM FIT GRADUATED COMP STOCKING GARTER BELT #111354 SOFT ENCLOSED TOE #101160 manufactured by Jobst Institute.
[9544]
Resident developed multiple pressure sores on his feet requiring skin ulceration treatments, physician assessement and antiobiotic therapy. Four of the sores were open and one was closed pressure area. This occurred approx 10-14 days after applying jobst custom fit graduated compression stockings for edema in the lower extremities.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 10987 |
| MDR Report Key | 10987 |
| Date Received | 1993-12-17 |
| 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 | 1994-01-21 |
| 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 | JOSCT CUSTOM FIT GRADUATED COMP STOCKING |
| Generic Name | VELCRO GARTER BELT L & R THIGH LENGTH SUPPORT W/TOE |
| Product Code | LLK |
| Date Received | 1993-12-17 |
| Model Number | GARTER BELT #111354 |
| Catalog Number | SOFT ENCLOSED TOE #101160 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 14 DAY |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 10987 |
| Manufacturer | JOBST INSTITUTE |
| Manufacturer Address | TOLEDO OH 43605 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-12-17 |