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

Model Number 5196501022

Device Problem Insufficient Information (3190)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Blood Loss (2597)

Event Date 09/24/2015

Event Type  Injury  

Manufacturer Narrative

The device remains implanted.Without the benefit of analyzing the device, qa cannot confirm any observations and cannot comment on the condition of the prosthesis.If the device becomes available, or additional information is received, qa will re-evaluate this complaint in accordance to procedures.However, because qa's examination may not conclusively confirm or disprove the report of vaginal pain and perception of a foreign body with bleeding judged as abnormal, qa accepts the physician's observations.A review of the complaint history database revealed no trends for this lot.Review of nonconforming reports revealed no nonconformances for this lot.No capas are associated with this lot.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

According to the available information, a (b)(6) year old patient experienced vaginal pain after altis procedure.Date of event onset: (b)(6) 2015.Description of the event : vaginal pain during physical activities (intensity=5).Vaginal pain and perception of a foreign body with bleeding judged as abnormal.Action/treatment: no treatment.Status: resolved.Date of resolution: (b)(6) 2015.Device still implanted in patient on (b)(6) 2015.Additional information received stated, treatment: colposeptine (chlorquinaldol and promestriene) during 10 days (morning and evening).

• 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: sarah o'gara ; 1601 west rivier road north; minneapolis, MN 55411 ; 6123578517
• MDR Report Key: 8655134
• MDR Text Key: 146535719
• Report Number: 2125050-2019-00438
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• PMA/PMN Number: K121562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial
• Report Date: 05/29/2019

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: 5196501022
• Device Catalogue Number: 519650
• Device Lot Number: 4456133
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/14/2019
• Initial Date FDA Received: 05/30/2019
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR