MAUDE Adverse Event Report: ACELL, INC. GENTRIX SURGICAL MATRIX THIN

Model Number PSM0412

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

Patient Problem Seroma (2069)

Event Type  Injury  

Manufacturer Narrative

This mdr is being submitted due to the reported seroma formation after initial placement of the acell device.It is unknown when the acell device was implanted and if it was explanted.The device is not available for evaluation.A review of the manufacturing records for this lot identified no deviations in the production process that fall outside of specification.

Event Description

On 3/6/2019, acell, inc.Was notified by a surgeon that a patient experienced a seroma post operative after a hiatal hernia repair procedure with an acell device, date of procedure was not provided.The patient required reoperation for other reasons; it is unknown if the reoperation was related to the seroma.Surgeon used the acell device prophylactically on a midline laparotomy closure; the laparotomy was created to perform hiatal hernia repair but not used to reinforce the hiatus.The surgeon prefers to insert the device in the valley of the defect and then close the subcutaneous flap.

• Brand Name: GENTRIX SURGICAL MATRIX THIN
• Type of Device: GENTRIX SURGICAL MATRIX THIN
• Manufacturer (Section D): ACELL, INC.; 6640 eli whitney dr.; columbia MD 21046
• Manufacturer (Section G): ACELL, INC.; 6640 eli whitney dr.; columbia MD 21046
• Manufacturer Contact: barry brainard ; 6640 eli whitney dr.; columbia, MD 21046 ; 4109538558
• MDR Report Key: 8484988
• MDR Text Key: 141018869
• Report Number: 3005920706-2019-00004
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: PSM0412
• Device Catalogue Number: PSM0412
• Device Lot Number: 010293
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2017
• 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