MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER BONE ANCHOR FOR SOFT TISSUE ATTACHMENT; STAPLE, FIXATION, BONE

Model Number M0068201110

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

Patient Problems Erosion (1750); Unspecified Infection (1930); Pain (1994); Scarring (2061)

Event Type  Injury  

Event Description

As reported by the patient¿s attorney, a protegen sling was implanted on (b)(6) 1997.According to the complainant, the patient experienced mesh erosion, pain, vaginal scarring, recurrent infections and dyspareunia.The patient had surgery to treat erosion on (b)(6) 1997 and another surgery to treat persistent discharge on (b)(6) 1998.All other information is unknown.Should additional relevant details become available, a supplemental report will be submitted.

Manufacturer Narrative

The reported lot number, 675060, could not be matched to the reported device.Therefore, the lot expiration and device manufacture dates are unknown at this time.

Event Description

As reported by the patient¿s attorney, a vesica sling was implanted on (b)(6) 1997.According to the complainant, the patient experienced mesh erosion, pain, vaginal scarring, recurrent infections and dyspareunia.The patient had surgery to treat erosion on (b)(6) 1997 and another surgery to treat persistent discharge on (b)(6) 1998.All other information is unknown.Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: BONE ANCHOR FOR SOFT TISSUE ATTACHMENT
• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 4742280
• MDR Text Key: 20778062
• Report Number: 3005099803-2015-01062
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K932925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 04/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0068201110
• Device Catalogue Number: 820-111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/23/2015
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention