FDA Adverse Event
Injury
Summary report: N
ICEROSS DERMO SEAL-IN LINER
MDR report key: 831776
·
Received March 15, 2007
Report
- Report Number
- 1836248-2007-00002
- Event Type
- Injury
- Date Received
- March 15, 2007
- Date of Event
- January 15, 2007
- Report Date
- February 14, 2007
- Manufacturer
- OSSUR H/F
- Product Code
- ISS
- PMA / PMN Number
- exempt
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
INSPECTION OF THE LINER SHOWS NOTHING OUT OF THE ORDINARY. IT SEEMED IN GOOD CONDITION. THERE WAS MOST LIKELY A USER RELATED LOSS OF SUCTION, IE PATIENT DID NOT STEP INTO THE HARD SOCKET WELL ENOUGH TO REACH THE REQUIRED SUCTION. THERE WAS NO TECHNICAL FAILURE IN THE LINER ITSELF.
Description of Event or Problem · 1
"WALKING WITH WALKER. PROSTHESIS FELL OFF AND SHE FELL DOWN AND BROKE HER HIP. PATIENT IS RECOVERING FROM HIP REPLACEMENT SURGERY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ICEROSS DERMO SEAL-IN LINER | ISS | ISS | OSSUR H/F | I-461323 | 060721 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 92 YR | Hospitalization| R |