MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ALYTE Y-MESH GRAFT

Model Number Y100

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

Patient Problems Abdominal Pain (1685); Autoimmune Disorder (1732); Erosion (1750); Cyst(s) (1800); Dry Eye(s) (1814); Dyspnea (1816); Extreme Exhaustion (1843); Fatigue (1849); Fever (1858); Headache (1880); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Itching Sensation (1943); Memory Loss/Impairment (1958); Muscle Weakness (1967); Pain (1994); Abnormal Vaginal Discharge (2123); Blurred Vision (2137); Vomiting (2144); Sneezing (2251); Urinary Frequency (2275); Discomfort (2330); Injury (2348); Fasciitis (2375); Sore Throat (2396); Loss of consciousness (2418); Irritability (2421); Neck Pain (2433); Neck Stiffness (2434); Prolapse (2475); Eye Burn (2523); Weight Changes (2607); Dysuria (2684); Swollen Lymph Nodes/Glands (4432); Cramp(s) /Muscle Spasm(s) (4521); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.No sample received.

Event Description

It was reported that as a result of having a lyte y mesh implanted in 2016, the patient experienced various autoimmune syndrome induced by adjuvants symptoms like ailments since 2017, which includes chronic fatigue, muscle pain/stiffness, constant throat inflammation, auto immunity, brain fog, forgetfulness, dyspareunia, problems to defecate etc.It was further reported that since november 2019, the patient was unable to do any job and pain has increased.

Manufacturer Narrative

The reported event is inconclusive.The sample was not returned.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use which accompanies all devices currently addresses potential risks associated with surgically implanted materials.The instructions for use states in the adverse events: ¿complications associated with the proper implantation of the alyte® y-mesh graft may include, but are not limited to those typically associated with surgically implantable materials including: ¿ postoperative hematoma, seroma, abscess or fistula formation, or scarring which may occur following the implant procedure.¿ urinary retention, bladder outlet obstruction and other voiding and defecatory dysfunctions.These conditions may be associated with over-correction/too much tension placed on the implant.¿ perforations or lacerations of vessels, nerves, bladder, bowel, urethra, rectum, or any viscera, which may occur during the implantation procedure.¿ irritation at the operative wound site which may elicit a foreign body response that leads to wound dehiscence, inflammation and/or infection.¿ extrusion through vaginal epithelium or erosion into surrounding viscera and/or mucosa.¿ inflammation, sensitization, pain, dyspareunia, scarification, contraction, device migration and failure of the procedure resulting in recurrence of vaginal wall prolapse.¿ urinary incontinence (stress and urge)." 1994 = "l".2348, 1849, 2993 = "nl".H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : no sample received.

Event Description

It was reported that as a result of having alyte y mesh implanted in 2016, the patient experienced various autoimmune syndrome induced by adjuvants symptoms like ailments since 2017, which includes chronic fatigue, muscle pain/stiffness, constant throat inflammation, auto immunity, brain fog, forgetfulness, dyspareunia, problems to defecate etc.It was further reported that since november 2019, the patient was unable to do any job and pain has increased.

Manufacturer Narrative

2396, 1941="nl".H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

Per additional information received on 17may2021, the patient has experienced severe muscle aches, pain in the pelvic floor area, headaches, loss of concentration, brain fog, sore throat, increased irritability in the year 2017 after implantation of the product in the year 2016.Patient had autoinflammatory/autoimmunity syndrome induced by adjuvants in patient after a polypropylene mesh implantation (asia syndrome), and received neuromuscular massage, trigger point therapy, cranio-sacral therapy, dry-needling in the year 2019 and confirmed that the patient has developed asia syndrome after pelvic surgery in the year 2020.

Manufacturer Narrative

1750, 1932="l".2467, 1880, 1966="nl".

Event Description

Per additional information received on 01jun2021, patient experienced erosion, graves disease, palpitations, tension in the cervical muscles and shoulders, headache, inflammation, fatigue, muscle spasm and pain, knot, stiffness in the morning, abdominal pain, constipation, fecal bloating, hypertonic painful sphincter, dry eyes, sore throat, hypersensitivity, auto inflammatory syndrome induced by adjuvant, irritation, anal pus loss, infection, fibromyalgia, chronic fatigue syndrome, fascia, muscle lumps, fever, night sweats, weight loss and required additional surgical and non-surgical interventions.

Event Description

Per additional information received on 27jul2021, the patient has experienced palpitations, grave¿s disease, acute abdominal pain in the right fossa, suspected acute appendicitis, erosion in the upper part of anus, severe pain in the muscles over the body, pain in pelvic floor, autoimmune syndrome induced by adjuvants, hypothyroidism, chronic fatigue, general stiffness, loss of concentration, psoriasis in the hair, vaginal wall prolapse, burning and gritty sensation in the area of eyes, blurred vision, throat infections, painful red throat, mucous membrane swelling, sneezing, anal pus, dysuria, cystitis, alopecia, dyspnea, hemoptysis, tenderness, allergy, increased irritability, mesh infection with rectal breakthrough, pain with pressure, fibromyalgia and required additional surgical and non-surgical interventions.

Manufacturer Narrative

2475, 2421="l".2418, 2434, 2146, 2137="nl".H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Manufacturer Narrative

1843, 1958, 2092="nl".Correction: d4.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

Per additional information received on 18oct2021, the patient has experienced anal discomfort, blood, and pus on toilet paper, hemorrhagic lesions on the left and some internal lesions on the right irregularities of the mucosa, fibromyalgia, asia syndrome, right fosse pain, abdominal pain, vomiting, loss of appetite, diffuse muscle pains in shoulders, neck and in leg muscles, fatigue, prolapsed hemorrhoid, recurrent mesh erosion to rectum, suspected acute appendicitis, graves base dow disease, knots in the muscles, pain in pelvic floor area, cramping of pelvic floor muscles, frequent throat infections, small eczema spots, eye itching, swollen mucous membranes, sneezing, dry eye, pain at coitus, eyelid inflammation, dysuria, urinary frequency, cystitis, weight fluctuations, loss of concentration, sore throat, allergy and increased irritability, early stage of thyroiditis, headache, continuous pain, memory impairment, exhaustion, loss of large amount of pus from the anus, pussy discharge, mild (t3) hypertnreosis, brain fog and required additional non-surgical interventions.

• Brand Name: ALYTE Y-MESH GRAFT
• Type of Device: ALYTE Y-MESH GRAFT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 10317051
• MDR Text Key: 200379010
• Report Number: 1018233-2020-04741
• Device Sequence Number: 1
• Product Code: OTO
• UDI-Device Identifier: 00801741016158
• UDI-Public: (01)00801741016158
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K101722
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Model Number: Y100
• Device Catalogue Number: Y100
• Device Lot Number: HUZL0888
• Was Device Available for Evaluation?: No
• Device Age: 1 MO
• Date Manufacturer Received: 10/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2016
• 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
• Treatment: UNK.; UNK.
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 46 YR
• Patient Sex: Female