MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2006-10-20 for GELBODIES * manufactured by Trulife Ltd..
[520939]
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.
Patient Sequence No: 1, Text Type: D, B5
[7806115]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8020869-2006-00001 |
| MDR Report Key | 777190 |
| Report Source | 08 |
| Date Received | 2006-10-20 |
| Date of Report | 2006-10-19 |
| Date Mfgr Received | 2006-10-09 |
| Date Added to Maude | 2006-11-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Manufacturer Contact | OLIVE GUNNING |
| Manufacturer Street | UNIT 3, COOKSTOWN IND EST TALLAGHT |
| Manufacturer City | DUBLIN 24 |
| Manufacturer Country | EI |
| Manufacturer Phone | 14511755 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GELBODIES |
| Generic Name | * |
| Product Code | JZR |
| Date Received | 2006-10-20 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 764970 |
| Manufacturer | TRULIFE LTD. |
| Manufacturer Address | * DUBLIN 24 EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-10-20 |