FDA.reportPublic FDA data

MAUDE MDR 7104

MDR report key
7104
Report number
1418479-1993-09001
Event key
0
Event type
3
Date of event
1993-08-12
Date received
1993-11-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
999
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
D
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HULKA FALLOPIAN CLIP APPLICATORFALLOPIAN CLIP APPLICATORRICHARD WOLF GMBHHGD8388.848388.84135U3N*

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11993-11-1001. O

Event Narratives#

D

Patient 1

THE DEVICE WOULD NOT PUSH THE METAL SPRING OF A FALLOPIAN TUBE CLIP INTO PLACE. THE CLIP WAS DISCARDED AND ANOTHER WAS PLACED WITH NO APPARENT PROBLEM. THE APPLICATOR WAS INSPECTED AT THIS DISTRIBUTOR'S PLANT AND WAS FOUND TO HAVE A BENT SHAFT AND A BENT UPPER CLOSURE ROD. NO SPECIFIC CAUSE OF THE PROBLEM HAS BEEN DETERMINED.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. 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: NONE OR UNKNOWN. RESULTS OF EVALUATION: COMPONENT FAILURE. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.