MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OBTRYX SYSTEM - CURVED; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number 850-400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Pain (1994); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); Insufficient Information (4580)

Event Date 11/25/2008

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an obtryx was implanted on (b)(6) 2008.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); vaginal pain; perineum pain; rectal pain; painful intercourse; difficulties with bowel motions; damage; psychiatric injury surgical interventions: on an unspecified date the patient underwent further surgery regarding the obtryx implant under general anesthesia for the following purpose: cut out tape from erosion of tape / pain.On an unspecified date the patient underwent further surgery regarding the obtryx implant under general anesthesia for the following purpose: can not remember if i had further surgery for more removal of tape for continued pain.Nonsurgical treatments: the patient was treated with pain medication: ended/ allergron for the treatment of: vaginal pain and spasm.The patient was treated with other medication (please specify).The patient was treated with physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: to relieve vaginal pain /spasm.The patient was treated with injections (not associated with surgical treatment): botox for the treatment of: relieve pain and spasm.

Manufacturer Narrative

(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.

• Brand Name: OBTRYX SYSTEM - CURVED
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12929066
• MDR Text Key: 286077562
• Report Number: 3005099803-2021-06911
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K040787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 850-400
• Device Catalogue Number: 850-400
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 66 KG