MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-06-21 for UNKNOWN DELTA LITE PRODUCT manufactured by Depuy-raynham, A Div. Of Depuy Orthopaedics.
[126115]
The pt was an eight year old child. After 9 days of immobilization; there was an extensive lesion at her leg. The internal portion of the ankle and shins were affected. The orthopedic specialist has advised the pt to go to a dermatologist to treat her case. Facility does not have more comments about the actual conditions of the child.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-1999-00077 |
| MDR Report Key | 227871 |
| Report Source | 05 |
| Date Received | 1999-06-21 |
| Date Facility Aware | 1999-05-24 |
| Date Mfgr Received | 1999-05-24 |
| Date Added to Maude | 1999-06-22 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN DELTA LITE PRODUCT |
| Generic Name | CASTING PRODUCT |
| Product Code | LGF |
| Date Received | 1999-06-21 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 220967 |
| Manufacturer | DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS |
| Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 02767 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-06-21 |