FDA.reportPublic FDA data

MAUDE MDR 3893

MDR report key
3893
Report number
3893
Event key
0
Event type
3
Date of event
1992-10-06
Date received
1993-02-02
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
1GYNOTECHDILAPAN LAMINARIAGYNOTECH, INC.HDYSIZE 4MMYN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11993-02-0201. O

Event Narratives#

D

Patient 1

DILAPAN LAMINARIA INSERTED ON 10/5/92. UPON REMOVAL FROM CERVIX ON 10/6/92. DISTAL PORTION OF LAMINARIA FRAGMENTED IN THE PATIENT. ALL VISIBLE SIGNIFICANT FRAGMENTS WERE RETREIVED BY PHYSICIAN. PATIENT INFORMED. TO DATE, PATIENT HAS HAD NO COMPLICATIONS RELATED TO THIS EVENT. PHYSICIAN FEELS THAT THE PATIENT'S ANATOMICAL CONSTRICTURE OF THE CERVICAL CANAL MAY HAVE CONTRIBUTED TO THE EVENTDEVICE 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: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: DEVICE DISCARDED, OTHER. THE DEVICE WAS DESTROYED/DISPOSED OF.