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MAUDE MDR 3061

MDR report key
3061
Report number
3061
Event key
0
Event type
3
Date of event
1992-01-14
Date received
1992-08-19
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
1CHROMIC SUTURE NEEDLEETHICONHASNN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11992-08-1901. R

Event Narratives#

D

Patient 1

PATIENT HAD MODERATE AMOUNT OF BRIGHT, RED BLEEDING POST SURGICAL PROCEDURE. PATIENT REQUIRED SUTURING. TIP END OF NEEDLE BROKE INSIDE VAGINA. HEMOSTATIS OBTAINED. NEEDLE TIP NOT RECOVEREDINVALID 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. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NONE OR UNKNOWN. THE DEVICE WAS DESTROYED/DISPOSED OF.