ESSURE
Report
- Report Number
- 2951250-2019-11185
- Event Type
- Injury
- Date Received
- November 6, 2019
- Date of Event
- August 1, 2011
- Report Date
- May 13, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ('PAIN: RIGHT SIDE ABDOMEN'), VAGINAL HAEMORRHAGE ('ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)') AND MENORRHAGIA ('ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)/MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)') IN A 44-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841531) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED KIDNEY INFECTION, MIGRAINE HEADACHE, DEPRESSION, ANXIETY AND PELVIC PAIN. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2012, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND HEADACHE ("HEADACHES"). IN (B)(6) 2012, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2015, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN (B)(6) 2016, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). IN (B)(6) 2018, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATING"). ON (B)(6) 2019, THE PATIENT EXPERIENCED POST PROCEDURAL INFECTION ("POST REMOVAL FOUL SMELLING PUS COMING FROM UMBILICAL AREA, CULTURE SHOWED MIXED FLORA"), 7 YEARS 11 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED AMNESIA ("MEMORY FOG"), PELVIC PAIN ("PELVIC PAIN"), GASTROINTESTINAL DISORDER ("GI (GASTROINTESTINAL DISORDER) CONDITIONS"), CYSTIC FIBROSIS ("CYSTIC FIBROSIS"), STRESS ("STRESS"), DEPRESSION ("DEPRESSING"), ANGER ("ANGER"), ABDOMINAL PAIN UPPER ("STOMACH PAIN"), PAROSMIA ("SMELL METALLIC WIRED"), FEELING ABNORMAL ("BRAIN FOG"), EMOTIONAL DISORDER ("EMOTIONAL"), PREMATURE MENOPAUSE ("EARLY MENOPAUSE"), ANAEMIA ("ANEMIA"), THYROID DISORDER ("THYROID"), FRUSTRATION TOLERANCE DECREASED ("FRUSTRATION"), PRURITUS ("ITCHY FEELING"), MUSCLE TWITCHING ("TWITCHING"), ANXIETY ("ANXIOUS"), MALAISE ("SICK"), HYPERSOMNIA ("SLEEPING LOT"), MIGRAINE ("MIGRAINE"), PYREXIA ("FEVER") AND INFECTION ("INFECTION"). THE PATIENT WAS TREATED WITH SULFAMETHOXAZOLE;TRIMETHOPRIM (BACTRIM) AND SURGERY (ABLATION ((B)(6) 2014) AND TOTAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, HEADACHE, ALOPECIA, AMNESIA, POST PROCEDURAL INFECTION, PELVIC PAIN, FEELING ABNORMAL, MUSCLE TWITCHING AND MIGRAINE HAD RESOLVED, THE FATIGUE, ABDOMINAL DISTENSION, GASTROINTESTINAL DISORDER, CYSTIC FIBROSIS, STRESS, DEPRESSION, ANGER, ABDOMINAL PAIN UPPER, PAROSMIA, EMOTIONAL DISORDER, PREMATURE MENOPAUSE, ANAEMIA, THYROID DISORDER, FRUSTRATION TOLERANCE DECREASED, PRURITUS, ANXIETY, MALAISE AND HYPERSOMNIA OUTCOME WAS UNKNOWN, THE WEIGHT INCREASED WAS RESOLVING AND THE PYREXIA AND INFECTION HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN UPPER, ALOPECIA, AMNESIA, ANAEMIA, ANGER, ANXIETY, CYSTIC FIBROSIS, DEPRESSION, EMOTIONAL DISORDER, FATIGUE, FEELING ABNORMAL, FRUSTRATION TOLERANCE DECREASED, GASTROINTESTINAL DISORDER, HEADACHE, HYPERSOMNIA, INFECTION, MALAISE, MENORRHAGIA, MIGRAINE, MUSCLE TWITCHING, PAROSMIA, PELVIC PAIN, POST PROCEDURAL INFECTION, PREMATURE MENOPAUSE, PRURITUS, PYREXIA, STRESS, THYROID DISORDER, VAGINAL HAEMORRHAGE, AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 185 LBS. POST OPERATIVE INFECTION: NO FURTHER DRAINAGE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.7 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD: MENORRHAGIA, MEMORY LOSS, WEIGHT GAIN, BLOATING, FATIGUE, HAIR LOSS AND POST PROCEDURAL INFECTION". QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: SOCIAL MEDIA WAS RECEIVED. EVENT ADDED- CYSTIC FIBROSIS, STRESS, DEPRESSION, ANGER, STOMACH PAIN, METALLIC SMELL, BRAIN FOG, EMOTIONAL, FEEL HORRIBLE, EARLY MENOPAUSE, ANEMIA, THYROID, FRUSTRATION, ITCHY FEELING, TWITCHING, ANXIOUS, SICK, SLEEPING, HEADACHES, MIGRAINE, FEVER, INFECTION. REPORTER WERE ADDED. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ('PAIN: RIGHT SIDE ABDOMEN'), VAGINAL HAEMORRHAGE ('ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)') AND MENORRHAGIA ('ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)/MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)') IN A 44-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841531) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED KIDNEY INFECTION, MIGRAINE HEADACHE, DEPRESSION, ANXIETY AND PELVIC PAIN. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2012, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND HEADACHE ("HEADACHES"). IN (B)(6) 2012, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2015, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN (B)(6) 2016, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). IN (B)(6) 2018, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATING"). ON (B)(6) 2019, THE PATIENT EXPERIENCED POST PROCEDURAL INFECTION ("POST REMOVAL FOUL SMELLING PUS COMING FROM UMBILICAL AREA, CULTURE SHOWED MIXED FLORA"), 7 YEARS 11 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED AMNESIA ("MEMORY FOG"), PELVIC PAIN ("PELVIC PAIN") AND GASTROINTESTINAL DISORDER ("GI (GASTROINTESTINAL DISORDER) CONDITIONS"). THE PATIENT WAS TREATED WITH SULFAMETHOXAZOLE;TRIMETHOPRIM (BACTRIM) AND SURGERY (ABLATION ((B)(6) 2014) AND TOTAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, HEADACHE, ALOPECIA, AMNESIA, POST PROCEDURAL INFECTION AND PELVIC PAIN HAD RESOLVED, THE FATIGUE, ABDOMINAL DISTENSION AND GASTROINTESTINAL DISORDER OUTCOME WAS UNKNOWN AND THE WEIGHT INCREASED WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALOPECIA, AMNESIA, FATIGUE, GASTROINTESTINAL DISORDER, HEADACHE, MENORRHAGIA, PELVIC PAIN, POST PROCEDURAL INFECTION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 185 LBS. POST OPERATIVE INFECTION: NO FURTHER DRAINAGE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.7 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD: MENORRHAGIA, MEMORY LOSS, WEIGHT GAIN, BLOATING, FATIGUE, HAIR LOSS AND POST PROCEDURAL INFECTION". QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-NOV-2019: PLAINTIFF FACT SHEET RECEIVED. EVENTS¿ PELVIC PAIN AND GI (GASTROINTESTINAL DISORDER) CONDITIONS WERE ADDED. EVENTS¿ ABDOMINAL PAIN, MENORRHAGIA, VAGINAL BLEEDING, AND POSTOPERATIVE INFECTION¿ WERE UPDATED TO RECOVERED/RESOLVED¿. WE RECEIVED A LOT NUMBER 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ('PAIN: RIGHT SIDE ABDOMEN'), VAGINAL HAEMORRHAGE ('ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)') AND MENORRHAGIA ('ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)') IN A 44-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841531) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED KIDNEY INFECTION, MIGRAINE HEADACHE, DEPRESSION, ANXIETY AND PELVIC PAIN. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2012, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND HEADACHE ("HEADACHES"). IN (B)(6) 2012, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2015, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN (B)(6) 2016, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). IN (B)(6) 2018, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATING"). ON (B)(6) 2019, THE PATIENT EXPERIENCED POST PROCEDURAL INFECTION ("POST REMOVAL FOUL SMELLING PUS COMING FROM UMBILICAL AREA, CULTURE SHOWED MIXED FLORA"), 7 YEARS 11 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED AMNESIA ("MEMORY FOG"). THE PATIENT WAS TREATED WITH SULFAMETHOXAZOLE;TRIMETHOPRIM (BACTRIM) AND SURGERY (ABLATION ((B)(6) 2014) AND TOTAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, HEADACHE, ALOPECIA AND AMNESIA HAD RESOLVED, THE VAGINAL HAEMORRHAGE, MENORRHAGIA, FATIGUE, ABDOMINAL DISTENSION AND POST PROCEDURAL INFECTION OUTCOME WAS UNKNOWN AND THE WEIGHT INCREASED WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALOPECIA, AMNESIA, FATIGUE, HEADACHE, MENORRHAGIA, POST PROCEDURAL INFECTION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 185 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.7 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD: MENORRHAGIA, MEMORY LOSS, WEIGHT GAIN, BLOATING, FATIGUE, HAIR LOSS AND POST PROCEDURAL INFECTION". QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-NOV-2019: QUALITY-SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT). WE RECEIVED A LOT NUMBER 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ('PAIN: RIGHT SIDE ABDOMEN'), VAGINAL HAEMORRHAGE ('ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)') AND MENORRHAGIA ('ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)') IN A (B)(6) YEAR OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841531) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED KIDNEY INFECTION, MIGRAINE HEADACHE, DEPRESSION, ANXIETY AND PELVIC PAIN. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2012, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND HEADACHE ("HEADACHES"). IN (B)(6) 2012, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2015, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN (B)(6) 2016, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). IN (B)(6) 2018, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATING"). ON (B)(6) 2019, THE PATIENT EXPERIENCED POST PROCEDURAL INFECTION ("POST REMOVAL FOUL SMELLING PUS COMING FROM UMBILICAL AREA, CULTURE SHOWED MIXED FLORA"), 7 YEARS 11 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED AMNESIA ("MEMORY FOG"). THE PATIENT WAS TREATED WITH SULFAMETHOXAZOLE;TRIMETHOPRIM (BACTRIM) AND SURGERY (ABLATION ((B)(6) 2014) AND TOTAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, HEADACHE, ALOPECIA AND AMNESIA HAD RESOLVED, THE VAGINAL HAEMORRHAGE, MENORRHAGIA, FATIGUE, ABDOMINAL DISTENSION AND POST PROCEDURAL INFECTION OUTCOME WAS UNKNOWN AND THE WEIGHT INCREASED WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALOPECIA, AMNESIA, FATIGUE, HEADACHE, MENORRHAGIA, POST PROCEDURAL INFECTION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT (B)(6). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.7 KG/SQM. HYSTEROSALPINGOGRAM ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD: MENORRHAGIA, MEMORY LOSS, WEIGHT GAIN, BLOATING, FATIGUE, HAIR LOSS AND POST PROCEDURAL INFECTION". MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-OCT-2019: PLAINTIFF FACT SHEET AND MEDICAL RECORD RECEIVED. THE CASE WAS UPGRADED FROM OTHER EVENT TO INCIDENT. PREVIOUSLY REPORTED EVENT¿ INJURY¿ WAS UPDATED TO MORE SPECIFIED EVENTS¿ PAIN: RIGHT SIDE ABDOMEN, ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA); HEADACHES, FATIGUE, BLOATING, HAIR LOSS, WEIGHT GAIN, MEMORY FOG, AND POST REMOVAL FOUL SMELLING PUS COMING FROM UMBILICAL AREA, CULTURE SHOWED MIXED FLORA¿¿. REPORTER, DEMOGRAPHICS, MEDICAL HISTORY, LAB DATA, ESSURE INDICATION AMENDED, ESSURE INSERTION/REMOVAL DATE; ESSURE LOT NUMBER, AND TREATMENT MEDICATION WERE ADDED. WE RECEIVED A LOT NUMBER 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1079116 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 841531 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Other| R |