UPSYLON
Report
- Report Number
- 3005099803-2021-07125
- Event Type
- Injury
- Date Received
- December 3, 2021
- Date of Event
- July 13, 2015
- Report Date
- October 13, 2022
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- OTO
- UDI-DI
- 08714729839217
- PMA / PMN Number
- K122794
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
CORRECTION TO BLOCK H6 - THE EVENT OF URGENCY AND WILL BE CAPTURED UNDER E1304: MICTURATION URGENCY. BLOCK A1: (B)(6). BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. THE UPN PROVIDED WAS CHOSEN AS A REPRESENTATIVE UPN TO CAPTURE THE IMPLANTED DEVICE. BLOCK H10: THE COMPLAINANT INDICATED THAT THE DEVICE IS NOT AVAILABLE FOR RETURN; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
BLOCK A1: (B)(6). BLOCK B3 DATE OF EVENT: DATE OF EVENT WAS APPROXIMATED TO JULY 13, 2015, IMPLANT PROCEDURE DATE, AS NO EVENT DATE WAS REPORTED. BLOCK E1: THIS EVENT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATION. THE IMPLANT SURGEON IS: DR. (B)(6) HOSPITAL AUSTRALIA. BLOCK H6: PATIENT CODES E232401, E2330, E1405, E1007 CAPTURE THE REPORTABLE EVENTS OF FECAL INCONTINENCE, PAIN, DYSPAREUNIA AND SWELLING. IMPACT CODES F19, F12 AND F2303 CAPTURE THE REPORTED EVENTS OF PATIENT SEEKING A LEGAL CLAIM RELATED TO THE INJURIES RELATED TO THE DEVICE, SURGICAL INTERVENTION AND MEDICATIONS.
BLOCK H2: BLOCKS A1, B5, B7, D4, G1, H4 AND H6 HAVE BEEN UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED ON AUGUST 24, 2022. CORRECTION: BLOCK B3 HAS BEEN CORRECTED BASED ON THE BASED ON THE ADDITIONAL INFORMATION RECEIVED ON AUGUST 24, 2022. BLOCK A1: (B)(6). BLOCK B3 DATE OF EVENT: DATE OF EVENT WAS APPROXIMATED TO (B)(6) 2015, IMPLANT PROCEDURE DATE, AS NO EVENT DATE WAS REPORTED. BLOCK E1: THIS EVENT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATION. THE IMPLANT SURGEON IS: DR. (B)(6). (B)(6) HOSPITAL. AUSTRALIA. BLOCK H6: PATIENT CODES E232401, E2330, E1405 CAPTURE THE REPORTABLE EVENTS OF FECAL INCONTINENCE, PAIN AND DYSPAREUNIA. IMPACT CODES F19, F12 AND F2303 CAPTURE THE REPORTED EVENTS OF PATIENT SEEKING A LEGAL CLAIM RELATED TO THE INJURIES RELATED TO THE DEVICE, SURGICAL INTERVENTION AND MEDICATIONS. CONCLUSION CODE D17 IS BEING USED IN LIEU OF AN ADEQUATE CONCLUSION CODE FOR DEVICE NOT RETURNED. BLOCK H10: THE COMPLAINANT INDICATED THAT THE DEVICE IS NOT AVAILABLE FOR RETURN; THEREFORE, A DEVICE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
(B)(6). THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. THE UPN PROVIDED WAS CHOSEN AS A REPRESENTATIVE UPN TO CAPTURE THE IMPLANTED DEVICE. THE COMPLAINANT INDICATED THAT THE DEVICE IS NOT AVAILABLE FOR RETURN; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPSYLON Y-MESH WAS IMPLANTED ON AN UNSPECIFIED DATE. THE PATIENT EXPERIENCED COMPLICATIONS, FURTHER SURGERY, AND NONSURGICAL TREATMENT. PATIENT SYMPTOMS INCLUDE: BACK PAIN; VAGINAL PAIN; PELVIC PAIN; GROIN PAIN; RECTAL PAIN; PAINFUL INTERCOURSE; DIFFICULTIES WITH BOWEL MOTIONS; AGGRAVATED INCONTINENCE SURGICAL INTERVENTIONS: ON (B)(6) 2020 THE PATIENT UNDERWENT FURTHER SURGERY REGARDING THE UPSYLON Y-MESH IMPLANT UNDER GENERAL ANESTHESIA FOR THE FOLLOWING PURPOSE: BOWEL INCONTINENCE AND URGENCY. NONSURGICAL TREATMENTS: ON (B)(6) 2015 THE PATIENT COMMENCED PAIN MEDICATION: PANADOL FOR: PAIN RELIEF. TREATMENT DURATION: 6 YEARS. ON (B)(6) 2020 THE PATIENT COMMENCED OTHER MEDICATION (PLEASE SPECIFY): CODEINE FOR THE TREATMENT OF: SEVERE PAIN. TREATMENT DURATION: 10 MONTHS. ON (B)(6) 2019 THE PATIENT COMMENCED OTHER (PLEASE SPECIFY): SCAN OF ABDOMEN/ PELVIS/ URINARY TRACT FOR THE TREATMENT OF: PAIN AND DISCOMFORT.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPSYLON Y-MESH WAS IMPLANTED ON AN UNSPECIFIED DATE. THE PATIENT EXPERIENCED COMPLICATIONS, FURTHER SURGERY, AND NONSURGICAL TREATMENT. PATIENT SYMPTOMS INCLUDE BACK PAIN; VAGINAL PAIN; PELVIC PAIN; GROIN PAIN; RECTAL PAIN; PAINFUL INTERCOURSE; DIFFICULTIES WITH BOWEL MOTIONS; AGGRAVATED INCONTINENCE. SURGICAL INTERVENTIONS: ON (B)(6) 2020, THE PATIENT UNDERWENT FURTHER SURGERY REGARDING THE UPSYLON Y-MESH IMPLANT UNDER GENERAL ANESTHESIA FOR THE FOLLOWING PURPOSE: BOWEL INCONTINENCE AND URGENCY. NONSURGICAL TREATMENTS: ON (B)(6) 2015, THE PATIENT COMMENCED PAIN MEDICATION: PANADOL FOR: PAIN RELIEF. TREATMENT DURATION: 6 YEARS. ON (B)(6) 2020, THE PATIENT COMMENCED OTHER MEDICATION (PLEASE SPECIFY): CODEINE FOR THE TREATMENT OF: SEVERE PAIN. TREATMENT DURATION: 10 MONTHS. ON (B)(6) 2019, THE PATIENT COMMENCED OTHER (PLEASE SPECIFY): SCAN OF ABDOMEN/ PELVIS/ URINARY TRACT FOR THE TREATMENT OF: PAIN AND DISCOMFORT. BOSTON SCIENTIFIC RECEIVED ADDITIONAL INFORMATION ON AUGUST 24, 2022, AS FOLLOWS: IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPSYLON Y-MESH DEVICE WAS IMPLANTED INTO THE PATIENT DURING A LAPAROSCOPIC SACROCOLPOPEXY AND LOW POSTERIOR REPAIR PROCEDURE PERFORMED ON (B)(6) 2015, FOR THE TREATMENT OF RECTOENTEROCELE. ON MARCH 7, 2018, THE PATIENT REPORTED PAIN DURING INTERCOURSE THAT WORSENED WITH STRAINING. SHE ALSO REPORTED ABDOMINAL SWELLING AND PAIN IN THE RIGHT ILIAC FOSSA. A PELVIC COMPUTED TOMOGRAPHY (CT) SCAN WAS REQUESTED FOR THE PATIENT. THE PATIENT SOUGHT A CONSULTATION FOR MIXED INCONTINENCE, WHICH WAS IMPACTING HER TENNIS GAME, ACCORDING TO THE DOCTOR'S RECOMMENDATION LETTER DATED SEPTEMBER 24, 2019. SHE HAS NOCTURIA AND WEARS PADS AT NIGHT. SHE HAS NEVER HAD A URINARY TRACT INFECTION AND DOES NOT HAVE A CHRONIC COUGH OR CONSTIPATION. RENAL FUNCTION AND MORPHOLOGY ARE ALSO NORMAL. THE FOLLOWING WERE THE RESULTS OF THE PATIENT'S PELVIC COMPUTED TOMOGRAPHY (CT) SCAN ON (B)(6) 2019. THERE IS EVIDENCE OF PREVIOUS PERINEAL SLING SURGERY WITH ANTERIOR DRAWING OF THE RECTUM'S BASE. THERE IS A SMALL RECTOCELE AND A MILD URETHROCELES. A HYSTERECTOMY IS NOTED. THE LIVER APPEARS TO BE NORMAL. THERE ARE CALCIFIED GALLSTONES. THE PANCREAS, SPLEEN, AND KIDNEYS ALL SEEM TO BE NORMAL.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPSYLON Y-MESH WAS IMPLANTED ON AN UNSPECIFIED DATE. THE PATIENT EXPERIENCED COMPLICATIONS, FURTHER SURGERY, AND NONSURGICAL TREATMENT. PATIENT SYMPTOMS INCLUDE: BACK PAIN; VAGINAL PAIN; PELVIC PAIN; GROIN PAIN; RECTAL PAIN; PAINFUL INTERCOURSE; DIFFICULTIES WITH BOWEL MOTIONS; AGGRAVATED INCONTINENCE. SURGICAL INTERVENTIONS: ON (B)(6) 2020 THE PATIENT UNDERWENT FURTHER SURGERY REGARDING THE UPSYLON Y-MESH IMPLANT UNDER GENERAL ANESTHESIA FOR THE FOLLOWING PURPOSE: BOWEL INCONTINENCE AND URGENCY. NONSURGICAL TREATMENTS: ON (B)(6) 2015 THE PATIENT COMMENCED PAIN MEDICATION: PANADOL FOR: PAIN RELIEF. TREATMENT DURATION: 6 YEARS. ON (B)(6) 2020 THE PATIENT COMMENCED OTHER MEDICATION (PLEASE SPECIFY): CODEINE FOR THE TREATMENT OF: SEVERE PAIN. TREATMENT DURATION: 10 MONTHS. ON (B)(6) 2019 THE PATIENT COMMENCED OTHER (PLEASE SPECIFY): SCAN OF ABDOMEN/ PELVIS/ URINARY TRACT FOR THE TREATMENT OF: PAIN AND DISCOMFORT. BOSTON SCIENTIFIC RECEIVED ADDITIONAL INFORMATION ON AUGUST 24, 2022 AS FOLLOWS: IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPSYLON Y-MESH DEVICE WAS IMPLANTED INTO THE PATIENT DURING A LAPAROSCOPIC SACROCOLPOPEXY AND LOW POSTERIOR REPAIR PROCEDURE PERFORMED ON (B)(6) 2015 FOR THE TREATMENT OF RECTOENTEROCELE. ON (B)(6) 2018, THE PATIENT REPORTED PAIN DURING INTERCOURSE THAT WORSENED WITH STRAINING. SHE ALSO REPORTED ABDOMINAL SWELLING AND PAIN IN THE RIGHT ILIAC FOSSA. A PELVIC COMPUTED TOMOGRAPHY (CT) SCAN WAS REQUESTED FOR THE PATIENT. THE PATIENT SOUGHT A CONSULTATION FOR MIXED INCONTINENCE, WHICH WAS IMPACTING HER TENNIS GAME, ACCORDING TO THE DOCTOR'S RECOMMENDATION LETTER DATED SEPTEMBER 24, 2019. SHE HAS NOCTURIA AND WEARS PADS AT NIGHT. SHE HAS NEVER HAD A URINARY TRACT INFECTION AND DOES NOT HAVE A CHRONIC COUGH OR CONSTIPATION. RENAL FUNCTION AND MORPHOLOGY ARE ALSO NORMAL. THE FOLLOWING WERE THE RESULTS OF THE PATIENT'S PELVIC COMPUTED TOMOGRAPHY (CT) SCAN ON (B)(6) 2019. THERE IS EVIDENCE OF PREVIOUS PERINEAL SLING SURGERY WITH ANTERIOR DRAWING OF THE RECTUM'S BASE. THERE IS A SMALL RECTOCELE AND A MILD URETHROCELES. A HYSTERECTOMY IS NOTED. THE LIVER APPEARS TO BE NORMAL. THERE ARE CALCIFIED GALLSTONES. THE PANCREAS, SPLEEN, AND KIDNEYS ALL SEEM TO BE NORMAL.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPSYLON Y-MESH WAS IMPLANTED ON AN UNSPECIFIED DATE. THE PATIENT EXPERIENCED COMPLICATIONS, FURTHER SURGERY, AND NONSURGICAL TREATMENT. PATIENT SYMPTOMS INCLUDE: BACK PAIN; VAGINAL PAIN; PELVIC PAIN; GROIN PAIN; RECTAL PAIN; PAINFUL INTERCOURSE; DIFFICULTIES WITH BOWEL MOTIONS; AGGRAVATED INCONTINENCE. SURGICAL INTERVENTIONS: ON (B)(6) 2020 THE PATIENT UNDERWENT FURTHER SURGERY REGARDING THE UPSYLON Y-MESH IMPLANT UNDER GENERAL ANESTHESIA FOR THE FOLLOWING PURPOSE: BOWEL INCONTINENCE AND URGENCY. NONSURGICAL TREATMENTS: ON (B)(6) 2015 THE PATIENT COMMENCED PAIN MEDICATION: PANADOL FOR: PAIN RELIEF. TREATMENT DURATION: 6 YEARS. ON (B)(6) 2020 THE PATIENT COMMENCED OTHER MEDICATION (PLEASE SPECIFY): CODEINE FOR THE TREATMENT OF: SEVERE PAIN. TREATMENT DURATION: 10 MONTHS. ON (B)(6) 2019 THE PATIENT COMMENCED OTHER (PLEASE SPECIFY): SCAN OF ABDOMEN/ PELVIS/ URINARY TRACT FOR THE TREATMENT OF: PAIN AND DISCOMFORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1825510 | UPSYLON | MESH, SURGICAL, SYNTHETIC | OTO | BOSTON SCIENTIFIC CORPORATION | M0068318200 | C002554 | 08714729839217 |
| 1825519 | UPSYLON | MESH, SURGICAL, SYNTHETIC | OTO | BOSTON SCIENTIFIC CORPORATION | M0068318200 | C002554 | 08714729839217 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Female | Required Intervention |