FDA Adverse Event
Other
Summary report: N
FAST T-FIX AB CURVED NEEDLE DELIVERY SYSTEM
MDR report key: 627211
·
Received August 12, 2005
Report
- Report Number
- 1219602-2005-00100
- Event Type
- Other
- Date Received
- August 12, 2005
- Date of Event
- July 8, 2005
- Report Date
- August 12, 2005
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- MBI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
SALES REP. REPORTED THAT A PT PRESENTED WITH POST-OPERATIVE LATERAL PAIN BEHIND THE KNEE AFTER A MENISCAL REPAIR PROCEDURE PERFORMED IN 2005. A SECOND SURGERY WAS PERFOMED WHERE CYSTS WERE NOTED AROUND THE T'S. THE SURGEON REMOVED THE CYSTS DURING THE 2ND SURGICAL PROCEDURE. THE SURGEON DID STATE THAT HE OBSERVED SOME CYSTS DURING THE INTIAL SURGERY. THE SURGEON STATED THAT THE PT IS 100% HEALED AS OF 08/2005.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FAST T-FIX AB CURVED NEEDLE DELIVERY SYSTEM | FAST-FIX AB | MBI | SMITH & NEPHEW, INC. | 7209399 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |