MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA

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

Patient Problems Hypersensitivity/Allergic reaction (1907); No Code Available (3191)

Event Date 09/01/2012

Event Type  Injury  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2012, approximated implant date, as the event reportedly occurred directly after the procedure.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Implant date: implant date was approximated to (b)(6) 2012 as the device was reportedly implanted in (b)(6) 2012; however, no specific date was provided.(b)(4).This complaint was reported by a nurse from allergy & asthma associates of maine where the allergy test was conducted.The implantation and removal of the device procedures were both performed at inland hospital in (b)(6).The complainant indicated that the removed device was disposed of and is not expected to be returned for evaluation; 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.

Event Description

It was reported to boston scientific corporation that a solyx sis system was implanted during a pelvic sling revision procedure performed on (b)(6) 2012.According to the complainant, directly after the procedure, the patient started to have an allergic reaction such as itchiness in the groin area.Subsequently, the mesh was removed from the patient but the mesh carriers are still embedded into the patient's groin as they reportedly cannot be easily removed.The mesh removal was performed at the same hospital where the device implantation was completed.At a different health care facility, a patch testing was done to the patient and a sample of the device mesh carrier has been requested to determine the next allergy test for the patient.Reportedly, the patient is still experiencing itchiness in the groin area.

• Brand Name: SOLYX SIS SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
• 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: 9109954
• MDR Text Key: 161681046
• Report Number: 3005099803-2019-04557
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/24/2019

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2019
• Initial Date FDA Received: 09/24/2019
• 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: 46 YR
• Patient Weight: 98