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

Model Number	5010002400
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Bacterial Infection (1735); Micturition Urgency (1871)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 supplemental reports, a follow-up report will be submitted.Device not explanted.
Event or Problem Description
As reported to coloplast, though not verified, the patient experienced urinary urgency, urge incontinence, sui, urinary leakage, constant drainage since surgery, yellow discharge, dyspareunia, urethral hypermobility with straining, grade 2 cystocele, recurrent uts and overactive bladder.Patient has been prescribed oral and topical medications to help with symptoms.

• Brand Name: EXAIR
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 12585747
• Report Number: 2125050-2021-01465
• Device Sequence Number: 11064077
• Product Code: OTP
• UDI-Device Identifier: 05708932459457
• UDI-Public: 05708932459457
• Combination Product (Y/N): N
• PMA/510(K) Number: K112386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/06/2021

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: Lay User/Patient
• Device Model Number: 5010002400
• Device Catalogue Number: 501000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 10/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR