FDA.reportPublic FDA data

MAUDE MDR 4931

MDR report key
4931
Report number
4931
Event key
0
Event type
3
Date of event
1992-06-26
Date received
1992-06-30
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ETHICONENDOPATH DISPOSABLE SURGICAL TROCARJOHNSON & JOHNSONFBQR0708CK 3519NN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11992-06-3001. R

Event Narratives#

D

Patient 1

PATIENT SCHEDULE FOR LAPROSCOPY TUBAL LIGATION. DURING LAPAROSCOPY PATIENT BEGAN BLEEDING IN ABDOMEN. MINI LAPAROSCOPY PERFORMED - PATIENT BLEEDING HEAVILY. VASCULAR SURGEONS TO OR. LAPAROSTOMY DONE FOR HEMKOSTASIS. PATIENT RECEIVED FOUR UNITS RBC'S ONE UNIT FFP. PATIENT TO ICUDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. 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 NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: NO DATA. THE DEVICE WAS DESTROYED/DISPOSED OF.