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U.S. Department of Health and Human Services

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

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ACELL, INC. GENTRIX SURGICAL MATRIX; GENTRIX SURGICAL MATRIX PLUS Back to Search Results
Model Number PSMX0710
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Dysphagia/ Odynophagia (1815)
Event Date 11/07/2018
Event Type  Injury  
Manufacturer Narrative
This mdr is being submitted due to the reported dysphagia which resulted in a two night hospitalization.The patient did not require intervention for the dysphagia and is now asymptomatic.The surgeon cannot confirm that the acell device was the cause of the reported symptoms.The surgeon is satisfied with the outcome of the patient.The acell device was not explanted and it is not available for evaluation.A review of the manufacturing records for this lot identified no deviations in the production process.The device was manufactured and distributed sterile in compliance with fda, state, local laws and regulations, and acell's operating procedures.There were no reports of device failure at the time of initial surgery.
 
Event Description
On 1/15/19, acell, inc.Was notified by a physician that their patient was complaining of having difficulty swallowing 9 weeks post-operative.The surgeon conducted a gastric bypass and hiatal hernia repair with an acell device on (b)(6) 2018.The patient presented with the symptoms at the er 9 weeks post-operative; an index ct scan was conducted which showed some narrowing.The patient was admitted to the hospital for 2 days.A ugi series and an egd with eus were performed.The results indicated the distal esophagus was patent with no obstruction and the eus revealed no significant fluid present.The patient did not require intervention for the dysphagia and is now asymptomatic.The surgeon cannot confirm that the acell device was related to the symptoms the patient reported and is satisfied with the outcome of the patient.The device was not explanted.
 
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Brand Name
GENTRIX SURGICAL MATRIX
Type of Device
GENTRIX SURGICAL MATRIX PLUS
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 Key8335351
MDR Text Key136016717
Report Number3005920706-2019-00002
Device Sequence Number1
Product Code FTM
UDI-Device Identifier00386190001370
UDI-Public(01)00386190001370(17)190531(10)008990
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162559
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 01/15/2019
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 Expiration Date05/31/2019
Device Model NumberPSMX0710
Device Catalogue NumberPSMX0710
Device Lot Number008990
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/15/2019
Initial Date FDA Received02/13/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/09/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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