MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPHOLD LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN

Model Number	M0068318170
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Incontinence (1928); Pain (1994); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505)
Date of Event	09/30/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a uphold lite was implanted into the patient on (b)(6) 2016.The patient experienced complications and nonsurgical treatment.Patient symptoms include: anal pain; rect pain; inab inter; diff bowel; incont not pres; psych.Nonsurgical treatments: on (b)(6) 2016 the patient commenced topical treatment (including oestrogen cream) for the treatment of: to assist functions and healing.
Additional Manufacturer Narrative
Patient identifier: (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.
Event or Problem Description
It was reported to boston scientific corporation that an uphold lite was implanted into the patient during a repair enterocele and perineal body + cystoscopy procedure performed on (b)(6) 2016 for prolapse.Postoperatively, the patient experienced complications and had nonsurgical treatment.Patient symptoms include anal pain, rectal pain, pain during intercourse, difficulty in bowel movement, incontinence not previously present, and psychiatric injury.On (b)(6) 2016, the patient had topical treatment including estrogen cream to heal and improve physical functions.
Additional Manufacturer Narrative
Block h2: additional information.The following have been updated: block a1 (additional identifier), block b5 narrative, block d4 (model number, lot number and expiration date), block e1 (additional contact below), block g1 manufacturing site, block h4 manufacturing date updated block a1: meshc-20211021-7ebe26d7 block e1: this complaint was reported by the patient's legal representation.The implant surgeon is: (b)(6).Block h6: patient code e1405, e0206, e2330 captures the reportable events of dyspareunia, unspecified psychiatric injury and pain.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: 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: UPHOLD LITE
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12929236
• Report Number: 3005099803-2021-06668
• Device Sequence Number: 5615440
• Product Code: OTP
• UDI-Device Identifier: 08714729839200
• UDI-Public: 08714729839200
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K122459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2019
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: ML00003536
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2021
• Supplement Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 12/03/2021
• Supplement Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 72 KG