FDA Adverse Event Summary report: N

SOLCO-TRANS

MDR report key: 5368 · Received March 15, 1993

Report

Report Number
5368
Date Received
March 15, 1993
Report Date
July 1, 1992
Manufacturer
SOLCO-BASLE HGP
Product Code
LWE
Report Source
User Facility report

Narratives

Description of Event or Problem · 1

PATIENT HAD RIGHT TOTAL HIP REPLACEMENT ON 5/29/92. SOLCOTRANS DRAIN IN PLACE AND DISCONTINUED LATER ON 5/29/92. NO DRAINAGE NOTED. PATIENT DEVELOPED CREPITUS IN RIGHT THIGH WHICH RESOLVED WITHIN DAYS. PATIENT READMITTED 6/10/92 FOR EVACUATION OF HEMATOMA ON RIGHT HIP AND THIGH.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: VISUAL EXAMINATION, OTHER. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA, OTHER. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE DISCARDED. THE DEVICE WAS DESTROYED/DISPOSED OF.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SOLCO-TRANS POST-OP AUTO TRANSFUSION SUSTEM LWE SOLCO-BASLE HGP ST-6500 UNKNOWN

Patients

Seq Age Sex Outcome Treatment
1 59 YR Invalid Data