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

Model Number 5196502400

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Erosion (1750); Calcium Deposits/Calcification (1758); Edema (1820); Foreign Body Reaction (1868); Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Pocket Erosion (2013); Urinary Tract Infection (2120); Blood Loss (2597); Dysuria (2684); No Code Available (3191); Constipation (3274)

Event Date 11/01/2017

Event Type  Injury  

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

As reported to coloplast though not verified, patient's legal representative stated foreign body reaction, mesh erosion, constant urinary tract infection, urinary problems, other injuries, significant mental and physical pain and suffering.

Manufacturer Narrative

This follow-up was created to document the additional device information.The lot number was reviewed for complaint trend, nonconforming reports and capa review.No trends were noted.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.

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

As reported to coloplast though not verified, additional information received, the patient also reported pain and bleeding.Post-operative bleeding, severe rectal pain, constipation, urinary leakage when rising from recumbent position, and recurrent uti with associated dysuria/flank pain, incontinence.Using 5-6 pads per day.(b)(6) 2017 6-8 mm piece of exposed suture at the right anterior bladder neck with calcifications and surrounding inflammation/edema.In office cystoscopy under local anesthesia.Altis erosion/embedded into right posterior bladder neck with surrounding edema, wet 80% of the time, >10 heavy pads/day, wakes up from sleep with sudden urge to urinate and is unable to get to the bathroom in time.(b)(6) 2017 1 cm altis exposure/erosion on the right bladder floor, lateral/proximal to ureteral orifice with inflammatory changes.In office cystoscopy under local anesthesia.(b)(6) 2018 - mixed incontinence, nocturia, urge urinary incontinence.

Manufacturer Narrative

This follow-up was created to document the additional event information, updated h6 codes.Device 3190- added for the exposure of the mesh.Patient 3191- nocturia and oab.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

As reported to coloplast though not verified, additional information received, urinary leakage when rising from recumbent position and recurrent uti with associated with dysuria/flank pain using 5-6 pads per day.(b)(6) 2017: 6-8 mm piece of exposed suture at the right anterior bladder neck with calcifications and surrounding inflammation/edema.In office cystoscopy under local anesthesia.Dysuria and recurrent utis.(b)(6) 2017: prior exposed suture was confirmed as altis erosion/embedded into right posterior bladder neck with surrounding edema.Cystoscopy under general anesthesia.(b)(6) 2017: worsening mui, pelvic pain, wet 80% of the time, >10 heavy pads/day, wakes up from sleep with sudden urge to urinate and is unable to get to the bathroom in time, jobless/homeless (sleeping in car or different homes).(b)(6) 2017" 1 cm altis exposure/erosion on the right bladder floor, lateral/proximal to ureteral orifice with inflammatory changes.In office cystoscopy under local anesthesia.(b)(6) 2017: mesh erosion, laser resection of eroded altis, and cystoscopy under general anesthesia.(b)(6) 2018 mixed incontinence and uti.(b)(6) 2018 sui and oab.(b)(6) 2018 stress urinary incontinence, nocturia, urge urinary incontinence, and unspecified leakage.

Event Description

Additional information received further reported that the patient experienced a urinary tract infection positive for aerococcus sanguinicola.The patient also experienced detrusor overactivity, low bladder capacity/compliance, and stress urinary incontinence which was much worse with illness/coughing.The patient went three weeks without any leakage at all, even with coughing, and was very happy with her mirabegron regime.She felt she had her life back from a urinary standpoint.Stress urinary incontinence symptoms were not bothersome to the patient, and she was not interested in an intervention.

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

• Brand Name: ALTIS KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west rivier road north; minneapolis MN 55411
• Manufacturer Contact: brian schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 6128651177
• MDR Report Key: 7866383
• MDR Text Key: 119882271
• Report Number: 2125050-2018-00667
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121562
• 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: 09/07/2022

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 Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 5076609
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/13/2018
• Initial Date FDA Received: 09/11/2018
• Supplement Dates Manufacturer Received: 08/13/2018; 08/13/2018; 08/13/2018; 08/13/2018; 09/10/2021
• Supplement Dates FDA Received: 02/14/2020; 04/30/2020; 06/17/2020; 07/30/2020; 09/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Female