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

Model Number M0068505000

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Irritation (1941); Pain (1994); Burning Sensation (2146); Injury (2348)

Event Date 03/17/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: other: hc adverse incident report reference (b)(4); submitted to hc (health canada) by the patient.The complaint device 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 an obtryx system - halo was implanted during a procedure performed on (b)(6) 2011.According to the complainant, on (b)(6) 2011, she has experienced fibromyalgia, pain in her nerves, and muscles which is, as per the patient, probably related to the "oxidation of the strip," radiating burning sensation under the skin, right groin, right hip, right leg, torn disc in her back, and the feeling of everything pulls to the right side including her pelvis.She also has experienced bursitis, tendinitis, other inflammation, extreme redness on her vulva which she reported to be a reaction to the implant, and immune response due to the "foreign body of plastic.".

• Brand Name: OBTRYX SYSTEM - HALO
• 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: 9262924
• MDR Text Key: 168076454
• Report Number: 3005099803-2019-05230
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729718987
• UDI-Public: 08714729718987
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K040787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/31/2019

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
• Device Expiration Date: 09/30/2013
• Device Model Number: M0068505000
• Device Catalogue Number: 850-500
• Device Lot Number: 1ML0090703
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/07/2019
• Initial Date FDA Received: 10/31/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other