Description of Event or Problem · 1
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF GENITAL HAEMORRHAGE ("HEAVY BLEEDING / BLEED FOR THREE MONTHS") AND ABDOMINAL PAIN ("ABDOMINAL PAIN/POKING ME ON THE LEFT SIDE OF MY BELLY/PAIN") IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810889) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: (B)(6) 2013, MAMMOGRAM: NO SPECIFIC MAMMOGRAPHIC CHANGES ARE SEEN TO SUGGEST MALIGNANCY. FINDINGS: THE PARENCHYMAL PATTERN DOES NOT APPEAR SIGNIFICANTLY CHANGED THAN THE PRIOR EXAMINATION THERE IS NO DOMINANT MASS OR SUSPICIOUS CLUSTERS OF MICRO CALCIFICATION. NIPPLE AND SKIN CONTOUR ARE NORMAL. (B)(6) 2013, MAMMOGRAM. DIAGNOSTIC DIGITAL ANALYSIS BILATERAL. IMPRESSION: THE BREAST PARENCHYMA IS STABLE WITH NO OBVIOUS TUMOR. THERE ARE STABLE AREAS OF MILD ASYMMETRY BILATERALLY THAT IS MOST LIKELY ASYMMETRIC BREAST PARENCHYMA ALONG WITH MINIMAL NODULARITY THAT IS STABLE. FINDINGS: DIGITAL IMAGES OF BOTH BREASTS WERE PERFORMED IN THE CC AND MLO PROJECTION WITH COMPUTER-AIDED DETECTION APPLIED IN ADDITION TO CONVENTIONAL VIEWS J A SPOT COMPRESSION VIEW WAS PERFORMED OF THE SUPERIOR ASPECT OF THE TIGHT BREAST IN THE MLO PROJECTION. COMPANION IS MADE TO PRIOR DIGITAL EXAMS OF (B)(6) 2012 AND (B)(6) 2012. THE PRIOR EXAM OF (B)(6) 2012 NOTED BILATERAL SMALL NODULARITY¿S ALONG WITH MILD ASYMMETRIC DENSITIES BILATERALLY. BOTH BREASTS REMAIN OF RATHER DENSE HETEROGENEOUS COMPLEX FIBRO GLANDULAR TISSUE RESULTING IN DECREASED SENSITIVITY INCREASING THE IMPORTANCE OF A CAREFUL CLINICAL EXAM ON THE INITIAL RIGHT R>.1LO PROJECTION SUPERIORLY AND POSTERIORLY THERE IS A SUGGESTION OF INCREASED DENSITY WHICH DISPERSES ON SPOT COMPRESSION VIEW AND IS CONSISTENT WITH A SUPERIMPOSITION SHADOW. (B)(6) 2012, MAMMOGRAM. DIAGNOSTIC DIGITAL ANALYSIS BILATERAL IMPRESSION: ACC: (B)(4) BILATERAL SIX-MONTH FOLLOW UP EXAMINATION ADVISED FOR BILATERAL BENIGN AREAS OF NODULARITY AND ASYMMETRY. NO SUSPICIOUS ABNORMALITY IS IDENTIFIED IN THE AREA OF PATIENT PAIN IN THE LEFT BREAST. CLINICAL FOLLOW UP IS RECOMMENDED. FURTHER MANAGEMENT SHOULD BE BASED ART THE LEVEL OF CLINICAL CONCERN. BI-RADS 3 PROBABLY BENIGN FINDINGS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"). IN (B)(6) 2011, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), ALOPECIA ("HAIR LOSS"), BACK PAIN ("BACK PAIN"), DEPRESSION ("DEPRESSION"), FATIGUE ("FATIGUE"), PELVIC DISCOMFORT ("DISCOMFORT"), PELVIC PAIN ("PAIN,") AND PROCEDURAL PAIN ("COMPLICATIONS OR PROBLEMS THAT OCCURRED AT THE TIME OF YOUR ESSURE PLACEMENT PROCEDURE : THE DOCTOR THEN GAVE HER ANESTHESIA ON HER LEFT SIDE BUT HE TOOK LONGER TO PUT IT THERE THAT THE ANESTHESIA WORE OFF AND SHE STARTED TO FEEL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPY ON (B)(6) 2011 AND PATIENT IS CURRENTLY PLANNING ESSURE REMOVAL). AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, ABDOMINAL PAIN, DYSMENORRHOEA, ALOPECIA, BACK PAIN, DEPRESSION, FATIGUE, MENORRHAGIA, VAGINAL HAEMORRHAGE, PELVIC DISCOMFORT, PELVIC PAIN, DYSPAREUNIA AND PROCEDURAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BACK PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC DISCOMFORT, PELVIC PAIN, PROCEDURAL PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PATIENT WAS PLANNING ESSURE REMOVAL AS THERE WAS LOT OF PAIN AND DISCOMFORT BUT SHE WAS ALSO AFRAID TO HAVE OTHER ORGANS REMOVED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULTS: FALLOPIAN TUBES WERE FULLY OCCLUDED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PREVIOUSLY REPORTED EVENT "COMPLICATIONS OR PROBLEMS THAT OCCURRED AT THE TIME OF YOUR ESSURE PLACEMENT PROCEDURE" PT UPDATED TO "PROCEDURAL PAIN" FROM PFS. ONSET DATE ADDED FOR THE EVENTS. INCIDENT WE RECEIVED A LOT NUMBER/RETURNED SAMPLE IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.