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

Model Number 5014202400

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Bacterial Infection (1735); Erythema (1840); Micturition Urgency (1871); Laceration(s) (1946); Nausea (1970); Pain (1994); Skin Erosion (2075); Urinary Tract Infection (2120); Burning Sensation (2146); Hematuria (2558); Dyspareunia (4505); Genital Bleeding (4507); Skin Inflammation/ Irritation (4545); Urinary Incontinence (4572)

Event Type  Injury  

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.No item number or lot number are known.Device not returned.

Event Description

As reported to coloplast, though not verified the patient experienced erosion and unspecified injuries.

Event Description

Additional information received further reported that between (b)(6) 2015 and (b)(6) 2019, the patient experienced: dyspareunia with continued vaginal burning for one week following intercourse, urinary urgency, post-coital vaginal soreness/pain, nausea, light bleeding, external irritation for one to three days following intercourse, splitting of vaginal skin at six o¿clock position, urinary tract infection positive for e.Coli, spotting, abdominal pressure with intercourse, post-coital bleeding, granulation tissue at the vaginal cuff, ammonia smell to urine, hematuria, and exposed mesh at the anterior vaginal wall, occasional urinary leakage when bending over/with activity, occasional stress urinary incontinence, random urge incontinence, and nocturia.The patient underwent in-office fulguration/cauterization of vaginal granulation tissue.Upon examination, there was a 1.5 x 0.5 cm area of exposed mesh in the anterior midline approximately two centimeters proximal to hymenal ring with some surrounding erythema and friable tissue.Exposed mesh had not responded to vaginal estrogen and prior electrocautery.Partial excision of the mesh took place, removal of ethibond sutures, and re-approximation of vaginal mucosa.

• Brand Name: RESTORELLE Y
• Type of Device: 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: 12583741
• MDR Text Key: 274965328
• Report Number: 2125050-2021-01460
• Device Sequence Number: 1
• Product Code: OTO
• Combination Product (y/n): N
• PMA/PMN Number: K112322
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2022

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/10/2017
• Device Model Number: 5014202400
• Device Catalogue Number: 501420
• Device Lot Number: 4241691
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2021
• Initial Date FDA Received: 10/06/2021
• Supplement Dates Manufacturer Received: 01/31/2022
• Supplement Dates FDA Received: 02/08/2022
• Date Device Manufactured: 09/11/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female