FDA Adverse Event
Injury
Summary report: N
UNKNOWN DELTA LITE PRODUCT
MDR report key: 227871
·
Received June 21, 1999
Report
- Report Number
- 1818910-1999-00077
- Event Type
- Injury
- Date Received
- June 21, 1999
- Manufacturer
- DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS
- Product Code
- LGF
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN DELTA LITE PRODUCT | CASTING PRODUCT | LGF | DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 8 YR | Required Intervention |