MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH XENFORM SOFT TISSUE REPAIR MATRIX; MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO

Model Number M0068302470

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

Patient Problem Urinary Tract Infection (2120)

Event Date 05/19/2016

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that the patient was implanted with xenform soft tissue repair matrix on (b)(6) 2015.According to the complainant, on (b)(6) 2016, the patient experienced urinary tract infection and was treated with (b)(6).The event is currently resolving.Additional information received on october 12, 2016 on (b)(6) 2016, the patient experienced a urinary tract infection.She was treated with (b)(6) and the event resolved on (b)(6) 2016.Additional information received on december 8, 2016 on (b)(6) 2016, the subject experienced a urinary tract infection.She was treated with (b)(6) and (b)(6) and the event resolved on (b)(6) 2016.Additional information available on march 28, 2017 the urinary tract infection formerly reported to have occurred on (b)(6) 2016 actually started on (b)(6) 2016.The (b)(6) 2016 urinary tract infection resolved on (b)(6) 2016.The (b)(6) 2016 urinary tract infection resolved on (b)(6) 2016.Additional information received on (b)(6) 2017 on (b)(6) 2017, the patient experienced urinary tract infection.She was treated with (b)(6) and the event resolved on (b)(6) 2017.

Event Description

It was reported to boston scientific corporation that the patient was implanted with xenform soft tissue repair matrix on (b)(6) 2015.According to the complainant, on (b)(6) 2016, the patient experienced urinary tract infection and was treated with (b)(6).The event is currently resolving.Additional information received on october 12, 2016 on (b)(6) 2016, the patient experienced a urinary tract infection.She was treated with (b)(6) and the event resolved on (b)(6) 2016.Additional information received on december 8, 2016 on (b)(6) 2016, the subject experienced a urinary tract infection.She was treated with (b)(6) and (b)(6) and the event resolved on (b)(6) 2016.Additional information available on march 28, 2017 the urinary tract infection formerly reported to have occurred on (b)(6) 2016 actually started on (b)(6) 2016.The (b)(6) 2016 urinary tract infection resolved on (b)(6) 2016.The (b)(6) 2016 urinary tract infection resolved on (b)(6) 2016.Additional information received on (b)(6) 2017 on (b)(6) 2017, the patient experienced urinary tract infection.She was treated with (b)(6) and the event resolved on (b)(6) 2017.

Event Description

It was reported to boston scientific corporation that the patient was implanted with xenform soft tissue repair matrix on (b)(6) 2015.According to the complainant, on (b)(6) 2016, the patient experienced urinary tract infection and was treated with (b)(6).The event is currently resolving.Additional information received on october 12, 2016 on (b)(6) 2016, the patient experienced a urinary tract infection.She was treated with (b)(6) and the event resolved on (b)(6) 2016.Additional information received on december 8, 2016 on (b)(6) 2016, the subject experienced a urinary tract infection.She was treated with (b)(6) and (b)(6) and the event resolved on (b)(6) 2016.Additional information available on march 28, 2017 the urinary tract infection formerly reported to have occurred on (b)(6) 2016 actually started on (b)(6) 2016.The (b)(6) 2016 urinary tract infection resolved on (b)(6) 2016.The (b)(6) 2016 urinary tract infection resolved on (b)(6) 2016.Additional information received on (b)(6) 2017 on (b)(6) 2017, the patient experienced urinary tract infection.She was treated with (b)(6) and the event resolved on (b)(6) 2017.

Event Description

It was reported to boston scientific corporation that the patient was implanted with xenform soft tissue repair matrix on (b)(6) 2015.According to the complainant, on (b)(6) 2016, the patient experienced urinary tract infection and was treated with (b)(6).The event is currently resolving.Additional information received on october 12, 2016 on (b)(6) 2016, the patient experienced a urinary tract infection.She was treated with (b)(6) and the event resolved on (b)(6) 2016.Additional information received on december 8, 2016 on (b)(6) 2016, the subject experienced a urinary tract infection.She was treated with (b)(6) and (b)(6) and the event resolved on (b)(6) 2016.Additional information available on march 28, 2017 the urinary tract infection formerly reported to have occurred on (b)(6) 2016 actually started on (b)(6) 2016.The (b)(6) 2016 urinary tract infection resolved on (b)(6) 2016.The (b)(6) 2016 urinary tract infection resolved on (b)(6) 2016.Additional information received on (b)(6) 2017 on (b)(6) 2017, the patient experienced urinary tract infection.She was treated with (b)(6) and the event resolved on (b)(6) 2017.

Event Description

It was reported to boston scientific corporation that the patient was implanted with xenform soft tissue repair matrix on (b)(6) 2015.According to the complainant, on (b)(6) 2016, the patient experienced urinary tract infection and was treated with (b)(6).The event is currently resolving.Additional information received on october 12, 2016 on (b)(6) 2016, the patient experienced a urinary tract infection.She was treated with (b)(6) and the event resolved on (b)(6) 2016.Additional information received on december 8, 2016 on (b)(6) 2016, the subject experienced a urinary tract infection.She was treated with (b)(6) and (b)(6) and the event resolved on (b)(6) 2016.Additional information available on march 28, 2017 the urinary tract infection formerly reported to have occurred on (b)(6) 2016 actually started on (b)(6) 2016.The (b)(6) 2016 urinary tract infection resolved on (b)(6) 2016.The (b)(6) 2016 urinary tract infection resolved on (b)(6) 2016.Additional information received on (b)(6) 2017 on (b)(6) 2017, the patient experienced urinary tract infection.She was treated with (b)(6) and the event resolved on (b)(6) 2017.

Event Description

It was reported to boston scientific corporation that the patient was implanted with xenform soft tissue repair matrix on (b)(6) 2015.According to the complainant, on (b)(6) 2016, the patient experienced urinary tract infection and was treated with sulfamethoxazole.The event is currently resolving.Additional information received on october 12, 2016: on (b)(6) 2016, the patient experienced a urinary tract infection.She was treated with sulfamethoxazole-trimethoprim and the event resolved on (b)(6) 2016.On (b)(6) 2016, the patient experienced a urinary tract infection.She was treated with sulfamethoxazole-trimethoprim and the event is currently resolving.Additional information received on december 8, 2016: on (b)(6) 2016, the subject experienced a urinary tract infection.She was treated with phenazopyridine hydrochloride and nitrofurantoin and the event resolved on (b)(6) 2016.Additional information available on march 28, 2017: the urinary tract infection formerly reported to have occurred on (b)(6) 2016 actually started on (b)(6) 2016.The (b)(6) 2016 urinary tract infection resolved on (b)(6) 2016.The (b)(6) 2016 urinary tract infection resolved on (b)(6) 2016.Additional information received on july 10, 2017: on (b)(6) 2017, the patient experienced urinary tract infection.She was treated with amoxicillin and the event resolved on (b)(6) 2017.Additional information received on december 27, 2017: on (b)(6) 2017, the patient experienced urinary tract infection.She was treated with cefuroxime and the event is resolving.

• Brand Name: XENFORM SOFT TISSUE REPAIR MATRIX
• Type of Device: MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 5820933
• MDR Text Key: 50387911
• Report Number: 3005099803-2016-02121
• Device Sequence Number: 1
• Product Code: PAJ
• Combination Product (y/n): N
• PMA/PMN Number: K060984
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/05/2016

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: Physician
• Device Expiration Date: 10/31/2017
• Device Model Number: M0068302470
• Device Lot Number: 0001502025
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/05/2016
• Initial Date FDA Received: 07/25/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 07/10/2017; 12/27/2017; 09/15/2018
• Supplement Dates FDA Received: 11/07/2016; 01/03/2017; 04/05/2017; 08/01/2017; 01/25/2018; 10/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 73