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

Model Number 5010002400

Device Problems Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Bacterial Infection (1735); Emotional Changes (1831); Erythema (1840); Fatigue (1849); Foreign Body Reaction (1868); Itching Sensation (1943); Nausea (1970); Pain (1994); Scar Tissue (2060); Sepsis (2067); Skin Erosion (2075); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Dysuria (2684); Constipation (3274); Genital Bleeding (4507); Rectovaginal Fistula (4509); Urinary Incontinence (4572)

Event Type  Injury  

Event Description

As reported to coloplast, though not verified, the patient with this device experienced abnormal vaginal discharge and bleeding, erosion of the device into her vaginal cuff, recurrent urinary incontinence, abdominal and vaginal pain, recurrent urinary tract infections, fatigue, vaginal odor, foreign body reaction, and other injuries.

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

Additional information received on 11/13/2022 as follows: on (b)(6) 2022 at ct of the abdomen/pelvis done for abdominal pain.Results showed questionable colovesical fistula with possible involvement of the vaginal cuff.On (b)(6) 2022 ed visit for intractable vomiting and left upper quadrant abdominal pain.Ct of the abdomin/pelvis shows possible colovaginal fistula and sepsis.On (b)(6) 2022 pelvic examination, rectal lavage, tap block, hand assisted laparoscopic retroperitoneal exploration, with sigmoid colectomy, fluorescent angiography under general anesthesia pathology report: colon, portion of sigmoid, suture marks the suspected region of colovaginal fistula with anastomotic rings, diverticulosis and diverticulitis, transmural defect, consistent with fistula.

Event Description

Additional information received further reported that a pelvic ultrasound showed a non-specific, small, somewhat prominent nonvascular tubular structure in the left adnexa.The patient experienced occasional blood per rectum when wiping.The patient also experienced erythema, urinary frequency, cystitis, a possible colovaginal fistula, and recurrent urinary tract infections.Urinary tract infections had been positive for escherichia coli and pseudomonas aeruginosa.The patient was prescribed cipro and macrobid.Botox seemed to be the only thing that has helped with pain.Synthetic mesh was exposed at the apex of the vagina.It was noted the patient also had a moderate to large cystocele and a urethral caruncle.The patient underwent mesh removal; the specimen consisted of 3 roughened ragged portions of mesh.No tissue was submitted for microscopic evaluation.Fluid collection near the left vaginal apex; mr pelvis report showed gas along the vaginal cuff, but no convincing evidence of colovaginal fistula.Subtle findings raised suspicion for rectovaginal fistula.Mri was recommended for further evaluation.There was a concern that mesh was adherent to the bowel.In april 2022, the patient attended an appointment with a colorectal surgeon to discuss upcoming combined surgery with urogynecology for mesh excision.There was still concern for an undetected fistula.

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.H6 code a01 "patient device interaction problem" applied to capture the reported "concern that mesh is adherent to the bowel.".

Event Description

Additional information received on 2/4/2023 indicates that the patient underwent an additional removal surgery on 5/11/2022.

Manufacturer Narrative

Correction: item number, udi number.The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.

Event Description

Additional information received 3/6/2023 as follows: between (b)(6) 2015 and (b)(6) 2022 the patient has experienced abdominal pain, vaginal itching, intermittent constipation, vaginal scarring, hospital admission for sepsis followed by a rash.

• Brand Name: EXAIR
• 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: 14780853
• MDR Text Key: 294676499
• Report Number: 2125050-2022-00640
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 05708932459457
• UDI-Public: 05708932459457
• Combination Product (y/n): N
• PMA/PMN Number: K121562
• 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,Followup,Followup
• Report Date: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/08/2016
• Device Model Number: 5010002400
• Device Catalogue Number: 501000
• Device Lot Number: 3951118
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/06/2023
• Date Device Manufactured: 12/09/2013
• 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: 79 YR