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

Model Number 5013202400

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

Patient Problems Wound Dehiscence (1154); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Erythema (1840); Inflammation (1932); Itching Sensation (1943); Pain (1994); Skin Erosion (2075); Abnormal Vaginal Discharge (2123); Burning Sensation (2146); Dizziness (2194); Malaise (2359); Prolapse (2475); Fibrosis (3167); Constipation (3274); Genital Bleeding (4507); Cramp(s) /Muscle Spasm(s) (4521); 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.

Event Description

As reported to coloplast, though not verified the patient with this device experienced chronic pain and a fibrotic reaction.It was reported that they also experienced erosion, recurrent incontinence, constipation, and recurrence of pelvic organ prolapse.The patient had many revision surgeries and had the mesh fully removed.

Event Description

Additional information received further reported that the patient underwent partial excision of unknown transobturator tape (tot) and implant of another manufacturer¿s implant.Restorelle m was used for sacrocolpopexy with ethibond sutures.The patient experienced intermittent pain, itching, and burning around episiotomy, vulvar/vaginal swelling, pelvic pressure, and her husband began feeling the mesh during intercourse.On exam, restorelle m and ethibond suture exposure (one centimeter) was identified at the vaginal apex.The patient underwent partial excision of the restorelle m mesh.The patient also experienced vaginal bleeding, discharge, cramping, and bacterial vaginosis symptoms after recent intercourse.Exposure of the restorelle m recurred (two centimeters in diameter) and the patient underwent partial excision of the mesh.At that time, the patient also underwent lysis of bowel adhesions, and vaginal apex re-attachment to the sacral portion of the restorelle m.The patient also experienced vaginal bleeding with odor, dizziness, fatigue, and was generally not feeling well; on exam, recurrent restorelle m and ethibond suture exposure were identified.The restorelle m was trimmed in the office.The patient underwent closure of the vaginal cuff incision dehiscence.During a vaginoscopy, the restorelle m and sutures were found eroded through the vagina.The restorelle m was completely excised; the patient also underwent partial vaginectomy, massive adhesiolysis, application of advaseal, cystoscopy, and rectosigmoidscopy.Intraoperative findings: erosion, significant phlegman mass/abscess surrounding the mesh, a small portion of the plegmon mass was left attached to a portion of the small bowel due to the risk of bowel perforation if it were to be removed.Subsequently, on exam, there was a dime-size area of redness at the top of the vagina.

Manufacturer Narrative

The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

• Brand Name: RESTORELLE M
• 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: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 13237147
• MDR Text Key: 283680642
• Report Number: 2125050-2022-00029
• Device Sequence Number: 1
• Product Code: OTO
• UDI-Device Identifier: 05708932483223
• UDI-Public: 05708932483223
• Combination Product (y/n): N
• PMA/PMN Number: K132061
• 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,Followup
• Report Date: 10/05/2022

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: 03/29/2020
• Device Model Number: 5013202400
• Device Catalogue Number: 501320
• Device Lot Number: 5550425
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/07/2022
• Initial Date FDA Received: 01/12/2022
• Supplement Dates Manufacturer Received: 04/10/2022; 09/23/2022
• Supplement Dates FDA Received: 04/20/2022; 10/05/2022
• Date Device Manufactured: 03/30/2017
• 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: 59 YR
• Patient Sex: Female