ESSURE
Report
- Report Number
- 2951250-2017-01629
- Event Type
- Injury
- Date Received
- April 25, 2017
- Date of Event
- August 1, 2014
- Report Date
- July 23, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
PROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN LOWER ("SEVERE LOWER ABDOMINAL PAIN"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("SHE WAS PREGNANT") AND GENITAL HAEMORRHAGE ("ABNORMAL HEAVY BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 862629 INVALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "LACK OF DEVICE EFFECT" IN (B)(6) 2014. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 3 (TOTAL NUMBER OF LIVE BIRTHS: 3 ((B)(6) 2005, (B)(6) 2009, (B)(6) 2011.) AND MISCARRIAGE IN 2007. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN (B)(6) 2014, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2015, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("PAINFUL POST-OPERATIVE RECOVERY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), MENORRHAGIA ("PROLONGED MENSES / ABNORMAL BLEEDING (MENORRHAGIA)"), BACK PAIN ("SEVERE BACK PAIN") AND PELVIC PAIN ("PAIN"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST, SECOND AND THIRD TRIMESTERS OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY IN (B)(6) 2015). ESSURE WAS REMOVED IN (B)(6) 2015. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN LOWER HAD RESOLVED, THE PREGNANCY WITH CONTRACEPTIVE DEVICE, PROCEDURAL PAIN, VAGINAL HAEMORRHAGE AND PELVIC PAIN OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, DYSMENORRHOEA, MENORRHAGIA AND BACK PAIN WAS RESOLVING. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE VAGINAL DELIVERY OCCURRED ON (B)(6) 2015. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, BACK PAIN, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, PROCEDURAL PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SINCE HAVING THE SURGERY, PLAINTIFF¿S SYMPTOMS ARE MOSTLY RESOLVED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: FULL OCCLUSION OF FALLOPIAN TUBES. ON (B)(6) 2014: HCG QUAL: POSITIVE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-JUL-2018: QUALITY DEPARTMENT MENTIONED THAT THE REPORTED LOT NUMBER WAS INVALID. FDA CODES WERE ADDED. NO FOLLOW-UP PTC INVESTIGATION WILL BE PROVIDED. INCIDENT NO VALID LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN LOWER ("SEVERE LOWER ABDOMINAL PAIN"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("SHE WAS PREGNANT") AND GENITAL HAEMORRHAGE ("ABNORMAL HEAVY BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 862629) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "LACK OF DEVICE EFFECT" IN AUGUST 2014. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 3 (TOTAL NUMBER OF LIVE BIRTHS: 3 ((B)(6) 2005, (B)(6) 2009, (B)(6) 2011.) AND MISCARRIAGE IN 2007. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN (B)(6) 2014, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2015, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("PAINFUL POST-OPERATIVE RECOVERY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), MENORRHAGIA ("PROLONGED MENSES / ABNORMAL BLEEDING (MENORRHAGIA)"), BACK PAIN ("SEVERE BACK PAIN") AND PELVIC PAIN ("PAIN"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST, SECOND AND THIRD TRIMESTERS OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY IN (B)(6) 2015). ESSURE WAS REMOVED IN JULY 2015. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN LOWER HAD RESOLVED, THE PREGNANCY WITH CONTRACEPTIVE DEVICE, PROCEDURAL PAIN, VAGINAL HAEMORRHAGE AND PELVIC PAIN OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, DYSMENORRHOEA, MENORRHAGIA AND BACK PAIN WAS RESOLVING. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, BACK PAIN, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, PROCEDURAL PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SINCE HAVING THE SURGERY, PLAINTIFF¿S SYMPTOMS ARE MOSTLY RESOLVED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: FULL OCCLUSION OF FALLOPIAN TUBES. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-FEB-2018: PLAINTIFF FACT SHEET RECEIVED. EVENTS VAGINAL BLEEDING & PELVIC PAIN ARE ADDED. EVENT VERBATIM FOR MENORRHAGIA WAS UPDATED. LOT NUMBER ADDED. LAB DATA UPDATED. CONCOMITANT & HISTORICAL CONDITIONS ADDED. PRODUCT, PATIENT & REPORTER INFORMATION UPDATED. INCIDENT AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN LOWER ("SEVERE LOWER ABDOMINAL PAIN"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("SHE WAS PREGNANT") AND GENITAL HAEMORRHAGE ("ABNORMAL HEAVY BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "LACK OF DEVICE EFFECT" IN (B)(6) 2014. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2015, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("PAINFUL POST-OPERATIVE RECOVERY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), MENORRHAGIA ("PROLONGED MENSES") AND BACK PAIN ("SEVERE BACK PAIN"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST, SECOND AND THIRD TRIMESTERS OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY IN (B)(6) 2015). ESSURE WAS REMOVED IN (B)(6) 2015. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN LOWER, GENITAL HAEMORRHAGE, DYSMENORRHOEA, MENORRHAGIA AND BACK PAIN WAS RESOLVING AND THE PREGNANCY WITH CONTRACEPTIVE DEVICE AND PROCEDURAL PAIN OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, BACK PAIN, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, PREGNANCY WITH CONTRACEPTIVE DEVICE AND PROCEDURAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SINCE HAVING THE SURGERY, PLAINTIFF'S SYMPTOMS ARE MOSTLY RESOLVED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: FULL OCCLUSION OF FALLOPIAN TUBES. QUALITY-SAFETY EVALUATION OF PTC: SAMPLE NOT AVAILABLE. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORDS. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME, ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. LACK OF EFFICACY CAN OCCUR WITH THE USE OF ANY PRODUCT AND IS NOT NECESSARY INDICATIVE OF A QUALITY DEFECT. THE REPORTED MEDICAL EVENTS ARE NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. AS NO BATCH NUMBER WAS REPORTED A TECHNICAL BATCH INVESTIGATION AND A REVIEW OF SIMILAR AE CASE REPORTS IS NOT POSSIBLE. NO COMPLAINT SAMPLE WAS PROVIDED FOR FURTHER INVESTIGATION THEREFORE THE COMPLAINT COULD NOT BE EVALUATED IN GREATER DETAIL. THE TECHNICAL ASSESSMENT CONCLUDED A QUALITY DEFECT WAS NOT CONFIRMED BUT CONSIDERED PLAUSIBLE. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS AND THE LACK OF EFFICACY EVENT CANNOT BE TOTALLY EXCLUDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-MAY-2017: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. COMPANY CAUSALITY COMMENT: THIS LITIGATION REPORT REFERS TO AN UNSPECIFIED AGED FEMALE PLAINTIFF WHO HAD (FALLOPIAN TUBE OCCLUSION INSERT) INSERTION ON (B)(6) 2011 AND GOT PREGNANT IN (B)(6) 2014. SHE ALSO REPORTED HAVING SEVERE LOWER ABDOMINAL PAIN AND ABNORMAL HEAVY BLEEDING (REGARDED AS GENITAL BLEEDING). THE PLAINTIFF GAVE BIRTH. SHE UNDERWENT BILATERAL SALPINGECTOMY IN (B)(6) 2015. UNINTENDED PREGNANCIES MAY OCCUR DURING ANY CONTRACEPTIVE USE AND HAVE BEEN REPORTED IN WOMEN WITH ESSURE MICRO-INSERT IN PLACE. SOME OF THESE PREGNANCIES OCCURRED DUE TO PATIENT NON COMPLIANCE WHICH INCLUDED FAILURE TO RETURN FOR THE ESSURE CONFIRMATION TEST. ABDOMINAL PAIN AND GENITAL BLEEDING ARE HIGHLY PREVALENT IN WOMEN, AND MAY HAVE MULTIPLE CAUSES. THIS CASE WAS CLASSIFIED AS INCIDENT SINCE SURGICAL INTERVENTION WAS REQUIRED. LACK OF EFFICACY CAN OCCUR WITH THE USE OF ANY PRODUCT AND IS NOT NECESSARY INDICATIVE OF A QUALITY DEFECT. THE REPORTED MEDICAL EVENTS ARE NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. AS NO BATCH NUMBER WAS REPORTED A TECHNICAL BATCH INVESTIGATION AND A REVIEW OF SIMILAR AE CASE REPORTS IS NOT POSSIBLE. NO COMPLAINT SAMPLE WAS PROVIDED FOR FURTHER INVESTIGATION THEREFORE THE COMPLAINT COULD NOT BE EVALUATED IN GREATER DETAIL. THE TECHNICAL ASSESSMENT CONCLUDED A QUALITY DEFECT WAS NOT CONFIRMED BUT CONSIDERED PLAUSIBLE. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS AND THE LACK OF EFFICACY EVENT CANNOT BE TOTALLY EXCLUDED. FOLLOW UP INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
THIS RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PREGNANCY WITH CONTRACEPTIVE DEVICE ("SHE WAS PREGNANT"), ABDOMINAL PAIN LOWER ("SEVERE LOWER ABDOMINAL PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL HEAVY BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "LACK OF DEVICE EFFECT" IN (B)(6) 2014. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), MENORRHAGIA ("PROLONGED MENSES") AND BACK PAIN ("SEVERE BACK PAIN"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST, SECOND AND THIRD TRIMESTERS OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY IN (B)(6) 2015). ESSURE WAS REMOVED IN (B)(6) 2015. IN (B)(6) 2015, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("PAINFUL POST-OPERATIVE RECOVERY"). AT THE TIME OF THE REPORT, THE PREGNANCY WITH CONTRACEPTIVE DEVICE AND PROCEDURAL PAIN OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN LOWER, GENITAL HAEMORRHAGE, DYSMENORRHOEA, MENORRHAGIA AND BACK PAIN WAS RESOLVING. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, BACK PAIN, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, PREGNANCY WITH CONTRACEPTIVE DEVICE AND PROCEDURAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SINCE HAVING THE SURGERY, PLAINTIFF'S SYMPTOMS ARE MOSTLY RESOLVED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: FULL OCCLUSION OF FALLOPIAN TUBES. COMPANY CAUSALITY COMMENT THIS LITIGATION REPORT REFERS TO AN UNSPECIFIED AGED FEMALE PLAINTIFF WHO HAD (FALLOPIAN TUBE OCCLUSION INSERT) INSERTION ON (B)(6) 2011 AND GOT PREGNANT IN (B)(6) 2014. SHE ALSO REPORTED HAVING SEVERE LOWER ABDOMINAL PAIN AND ABNORMAL HEAVY BLEEDING (REGARDED AS GENITAL BLEEDING). THE PLAINTIFF GAVE BIRTH. SHE UNDERWENT BILATERAL SALPINGECTOMY IN (B)(6) 2015. UNINTENDED PREGNANCIES MAY OCCUR DURING ANY CONTRACEPTIVE USE AND HAVE BEEN REPORTED IN WOMEN WITH ESSURE MICRO-INSERT IN PLACE. SOME OF THESE PREGNANCIES OCCURRED DUE TO PATIENT NON COMPLIANCE WHICH INCLUDED FAILURE TO RETURN FOR THE ESSURE CONFIRMATION TEST. ABDOMINAL PAIN AND GENITAL BLEEDING ARE HIGHLY PREVALENT IN WOMEN, AND MAY HAVE MULTIPLE CAUSES. THIS CASE WAS CLASSIFIED AS INCIDENT SINCE SURGICAL INTERVENTION WAS REQUIRED. A PRODUCT TECHNICAL ANALYSIS IS BEING SOUGHT. FOLLOW UP INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 302058 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 862629 INVALID |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Other| R |