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

Model Number 5013301022

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bacterial Infection (1735); Hematoma (1884); Pain (1994); Scar Tissue (2060)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported to coloplast, though not verified, between (b)(6) 2015 - (b)(6) 2015: postop abdominal pain, scar tissue infection.Ems to ed to observation admission ¿ left lower abdominal/back pain x 2 days, pain over l laparoscopic port site, fever, headaches, nausea, dysuria, constipation.3-4 cm palpable mass under port site in left iliac fossa, anemia.Abdominal ultrasound ¿ anechoic fluid collection 18 x 14 x 17 mm in left iliac fossa, 13 mm moderately echogenic area in anterior uterine wall.Left port site fluid collection/ hematoma.On (b)(6) 2020 - reassured claimant that endometriosis is the cause of ongoing symptoms/problems, not restorelle/coloplast.No other adverse patient effects were reported.

• Brand Name: RESTORELLE XL
• 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: 12833328
• MDR Text Key: 280941026
• Report Number: 2125050-2021-01664
• Device Sequence Number: 1
• Product Code: OTO
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/18/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: 5013301022
• Device Catalogue Number: 501330
• Device Lot Number: 4069249
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2021
• Initial Date FDA Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/19/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Sex: Female