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

Model Number 5010002400

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Numbness (2415); No Information (3190)

Event Date 01/01/2013

Event Type  Injury  

Manufacturer Narrative

The contract manufacturer reviewed the lot 1003027 & 1003028 dhr and stated specifications were met.Review of lot # for complaint trend, nonconforming report and capa review.No trends noted.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 information provided by health (b)(6) pain in the lower back and down hips to the bottom of the legs, pain in the right groin and right thigh still numb, difficulty walking.Drug taken for the bladder to avoid slenderness because if forgotten there is big slenderness.Pain in my stomach.No resistance a few months ago but had to reduce working hours due to difficulty working a full day.

• Brand Name: EXAIR ANTERIOR 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 river road north; minneapolis MN 55411
• Manufacturer Contact: sarah o'gara ; 1601 west river road north; minneapolis, MN 55411 ; 6123578517
• MDR Report Key: 9288361
• MDR Text Key: 168437361
• Report Number: 2125050-2019-00982
• 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: foreign,other
• Type of Report: Initial
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5010002400
• Device Lot Number: 2496755
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other