FDA.reportPublic FDA data

MAUDE MDR 4376

MDR report key
4376
Report number
4376
Event key
0
Event type
3
Date received
1993-01-15
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
1TROCARETHICON ENDOSURGERYFBQDDF-0922DH32KI**

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11993-01-1501. R

Event Narratives#

D

Patient 1

PATIENT WAS TO UNDERGO AN EXPLORATORY LAPROSCOPIC PROCEDURE. IT IS ASSUMED THAT DURING THE PLACEMENT OF THE TROCAR, THE DEVICE PUNCTURED THE BOWEL AND THE COMMON ILIAC ARTERY. THE INJURIES REQUIRED THE PATIENT'S ABDOMEN TO BE OPENED AND THE PUNCTURE WOUNDS OF THE BOWEL CLOSED WITH SUTURES AND REANASTOMOSIS OF THE ARTERYINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING 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. IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.