MAUDE Adverse Event Report: COLOPLAST A/S RESTORELLE DIRECTFIX ANTERIOR; SURGICAL MESH

Model Number	5014502400
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Erosion (1750); Foreign Body Reaction (1868); Micturition Urgency (1871); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Discomfort (2330); Genital Bleeding (4507); Urinary Incontinence (4572)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Coloplast has not been provided any corroborating evidence to verify the information contained in this report.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
Event or Problem Description
As reported to coloplast, though not verified, the patient with this device experienced unspecified bilateral leg pain from thighs to bottom of feet, with increasing lower back pain.
Additional Manufacturer Narrative
D4 lot number: 160315.
Event or Problem Description
Additional review determined that on (b)(6) 2019, the patient was experiencing or had experienced a urinary tract infection.Additional information received further reported the patient experienced foreign body reaction, erosion, unspecified urinary problems, vaginal bleeding and other unspecified injuries.
Additional Manufacturer Narrative
H6 code e2311 "discomfort" applied to capture "consortium complaint of poking sensation during intercourse." coloplast has not been provided any corroborating evidence to verify the information contained in this report.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
Event or Problem Description
Additional information received further reported that on the following dates, the patient had experienced or was experiencing the following: (b)(6) 2019: vaginal green discharge.Found to have vaginal erosion due to granulation tissue, cauterized with silver nitrate.(b)(6) 2019: 2 x 1 centimeter mesh exposure at the anterior wall near the apex.Cauterized with silver nitrite.Consortium complaint of poking sensation during intercourse.(b)(6) 2019: continued consortium complaint; anterior vaginal wall exposure of the mesh with a prolene stitch at the vaginal apex; 1.5 cm x 1.5 cm in dimension.Excised in the office.(b)(6) 2019: small 2 mm prolene suture can at the vaginal apex; 1 mm wide and 4 mm vaginal wall mesh exposure on the anterior vaginal wall.Excised in the office.(b)(6) 2019: unspecified bilateral leg pain from thighs to bottom of feet worsening over 2 weeks, with increasing lower back pain.(b)(6) 2019: claimant can still feel the mesh when she puts her finger in the vagina.Complaints of urinary incontinence with both stress and urge.Small 2 mm prolene suture at the vaginal apex.Slight 2 mm wide and 2 mm long anterior vaginal wall mesh exposure.(b)(6) 2019: excision of vaginal mesh and removal of prolene suture under local anesthesia.(b)(6) 2019: urinary urgency.

• Brand Name: RESTORELLE DIRECTFIX ANTERIOR
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 12269423
• Report Number: 2125050-2021-01055
• Device Sequence Number: 2772137
• Product Code: FTL
• UDI-Device Identifier: 05708932484022
• UDI-Public: 05708932484022
• Combination Product (Y/N): N
• PMA/510(K) Number: K103568
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/09/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5014502400
• Device Catalogue Number: 501450
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/11/2021
• Supplement Date Received by Manufacturer: 07/11/2021; 10/15/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 08/10/2021; 11/09/2021
• 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; Other
• Patient Age: 62 YR
• Patient Sex: Female