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Catalog Number PCDN1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nausea (1970); Pain (1994); Hernia (2240)
Event Type  Injury  
Manufacturer Narrative
(b)(4). To date, the device has not been returned. If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form. Mwr-12122018-0000273252 submitted for adverse event which occurred on (b)(6) 2015. Mwr-12122018-0000273259 submitted for adverse event which occurred on (b)(6) 2018. Mwr-12122018-0000273265 submitted for adverse event which occurred on (b)(6) 2018.
Event Description
It was reported by an attorney that the patient underwent incarcerated ventral hernia repair surgery on (b)(6) 2012 and mesh was implanted. It was reported that the patient underwent an open right colectomy with ileocolic anastomosis, omentectomy, lysis of adhesions, and the placement of an on-q pain pump on (b)(6) 2015. The surgeon noted omentum and small bowel adherent up to the prior mesh hernia repair allowing the unfixed cecum to twist around the omentum creating an internal hernia and hence cecal volvulus. It was also noted small bowel and omentum was densely adherent to the mesh and the areas where we did dissect small bowel of the mesh should effectively prevent any future problems related to the mesh with respect to the ascending colon, although the resection should take care of it definitely. It was reported that the patient underwent a laparoscopic lysis of adhesions, laparoscopic repair of two incarcerated incisional hernias and mesh excision on (b)(6) 2018 during which the surgeon noted massive intra-abdominal adhesions involving the previously placed abdominal wall mesh densely adherent to the transverse colon possibly at the anastomosis; recurrent incarcerated incisional hernia x2, evidence of partial bowel obstruction and removal of abdominal wall mesh. The surgeon also noted dense adhesions of both omentum and bowel to the anterior abdominal wall and what would appear to be the previously placed mesh. The surgeon also noted as the adhesiolysis continued, the edge of the previously placed mesh was densely adherent to the colon, which could not be taken down. The choice was to leave the mesh adhered to the bowel, take the mesh down, or sacrifice a portion of the colon to be able to remove the mesh. Because there was concern that the mesh may eventually erode to the colon, a colotomy was performed to remove the mesh from a small portion of the colon. It was further advised that the surgeon transitioned from a laparoscopic to an open procedure where a portion of the previously placed mesh was excised using the bovie electrocautery, yet the well incorporated mesh was left in place. It was further reported that the surgeon decided not to use mesh for fear of infection of the mesh. It was reported that the patient presented with an abdominal wall hematoma on (b)(6) 2018 during which the surgeon evacuated a clotted hematoma which measured approximately 700 cubic centimeters. It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss. No additional information is provided.
Manufacturer Narrative
In addition, a device history review has been inserted into the file. This review indicates that there was no quality concerns associated with the manufacturing process. No additional information was provided.
Manufacturer Narrative
Date sent to the fda: 5/6/2021.
Search Alerts/Recalls

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Manufacturer (Section D)
1000 route 202
raritan NJ 08876 0151
MDR Report Key8197518
MDR Text Key131480583
Report Number2210968-2018-77701
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup,Followup
Report Date 01/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2013
Device Catalogue NumberPCDN1
Device Lot NumberDEG178
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/02/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/26/2018 Patient Sequence Number: 1