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

Model Number	MSPL1015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr is being submitted due to the reported infection after initial placement of the acell device in conjunction with a kci (acelity) prevena negative pressure system.The acell device was explanted; however it 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.The device was manufactured and distributed sterile in compliance with fda, state, local, and acell's operating procedures.There were no reports of device failure at the time of initial surgery.We are submitting this report now, without results of sterility testing, in order to submit a timely report and will provide a follow-up upon completion of sterility testing.
Event or Problem Description
On 1/3/2019, acell, inc.Was notified by a physician that their patient developed an infection after application of an acell device and usage of kci (acelity) prevena negative pressure system.The surgeon conducted a colostomy reversal and parastomal hernia repair on (b)(6) 2018, an acell device was placed in an underlay technique and the fascia re-approximated.The skin was left open with kci (acelity) prevena negative pressure system applied to the area.During the first wound vacuum change, an infection was discovered.The surgeon is unsure if the device was the cause the infection.The surgeon performed a post-operative washout and debridement including the explanting of the acell device.There was no date provided of when this procedure was conducted.
Event or Problem Description
On 1/3/19, acell, inc.Was notified by a physician that their patient developed an infection after application of an acell device and usage of kci (acelity) prevena negative pressure system.The surgeon conducted a colostomy reversal and parastomal hernia repair on (b)(6) 2018, an acell device was placed in an underlay technique and the fascia re-approximated.The skin was left open with kci (acelity) prevena negative pressure system applied to the area.During the first wound vacuum change, an infection was discovered.The surgeon is unsure if the device was the cause the infection.The surgeon performed a post-operative washout and debridement including the explanting of the acell device.There was no date provided of when this procedure was conducted.
Additional Manufacturer Narrative
This is a follow-up report for additional information that was received subsequent to the initial filing.Acell conducted sterility testing on the same retained lot, results indicated no growth was observed.This mdr is being submitted due to the reported infection after initial placement of the acell device in conjunction with a kci (acelity) prevena negative pressure system.The acell device was explanted; however it 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.The device was manufactured and distributed sterile in compliance with fda, state, local, and acell's operating procedures.There were no reports of device failure at the time of initial surgery.

• Brand Name: GENTRIX SURGICAL MATRIX PLUS
• Common Device Name: GENTRIX SURGICAL MATRIX PLUS
• Manufacturer (Section D): ACELL, INC.; 6640 eli whitney dr.; columbia MD 21046
• MDR Report Key: 8297540
• Report Number: 3005920706-2019-00001
• Device Sequence Number: 2575231
• Product Code: FTM
• UDI-Device Identifier: 00386190001240
• UDI-Public: (01)00386190001240(17)200731(10)013211
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K162554
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: MSPL1015
• Device Catalogue Number: MSPL1015
• Device Lot Number: 013211
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/03/2019
• Supplement Date Received by Manufacturer: 01/03/2019
• Initial Report FDA Received Date: 02/01/2019
• Supplement Report FDA Received Date: 02/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: KCI (ACELITY) PREVENA NEGATIVE PRESSURE SYSTEM; KCI (ACELITY) PREVENA NEGATIVE PRESSURE SYSTEM; KCI (ACELITY) PREVENA NEGATIVE PRESSURE SYSTEM
• Outcome Attributed to Adverse Event: Required Intervention