FDA Adverse Event
Other
Summary report: N
GELBODIES
MDR report key: 777190
·
Received October 20, 2006
Report
- Report Number
- 8020869-2006-00001
- Event Type
- Other
- Date Received
- October 20, 2006
- Report Date
- October 19, 2006
- Manufacturer
- TRULIFE LTD.
- Product Code
- JZR
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FURTHER INFORMATION REQUESTED TO DETERMINE IF THE INCIDENT RESULTED IN SERIOUS INJURY. HAVE REQUESTED THAT THE DEVICE BE RETURNED FOR EVALUATION. AT THIS STAGE NOT POSSIBLE TO DETERMINE CAUSE.
Description of Event or Problem · 1
PATIENT REPORTED AN INJURY, WHEN USING HEEL / ELBOW GELBODIES, SIZE MEDIUM, AFTER USING THE PRODUCT FOR 2 WEEKS, THE PATIENT HAD A VERY RED AREA ON HER HEEL, WHICH REQUIRED NURSING CARE FROM A WOUND CARE SPECIALIST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GELBODIES | * | JZR | TRULIFE LTD. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |