MAUDE Adverse Event Report: COLOPLAST A/S EXAIR; OTP

Model Number 5010002400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Incontinence (1928); Muscle Spasm(s) (1966); Pain (1994); Urinary Tract Infection (2120); Prolapse (2475); Constipation (3274)

Event Date 03/24/2014

Event Type  Injury  

Event Description

As reported to coloplast though not verified, patient was implanted with exair mesh.Later the patient experienced nocturia, back pain, urinary tract infection, vaginal discomfort, vaginal muscle spasms, pain to si joint, pelvis and thigh, constipation worse since surgery, incontinence, an exam revealed palpable vaginal mesh and recurrent pelvic organ prolapse.Opioid pain medication, vaginal valium, lipitor, pelvic therapy, asprin, antibiotics and premarin cream were prescribed.Constipation managed with stool softeners and prunes.An excision of the mesh was performed.

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.(b)(4).Device not returned.

• Brand Name: EXAIR
• Type of Device: OTP
• Manufacturer (Section D): COLOPLAST A/S; holtedam-1; humlebaek 3050, dk
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 w. river road n.; minneapolis MN 55411
• Manufacturer Contact: angela kilian-head of ra ; 1601 w. river road n.; minneapolis, MN 55411 ; 6122874236
• MDR Report Key: 4332738
• MDR Text Key: 21170860
• Report Number: 2125050-2014-00436
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K112386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 12/16/2014

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: Other
• Device Expiration Date: 05/22/2016
• Device Model Number: 5010002400
• Device Catalogue Number: 5010002400
• Device Lot Number: 3704903
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/16/2014
• Initial Date FDA Received: 12/16/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/23/2013
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 75 YR