MAUDE Adverse Event Report: LIFECELL UNKNOWN STRATTICE; MESH, SURGICAL

Catalog Number UNK STRATTICE

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

Patient Problem Seroma (2069)

Event Type  Injury  

Manufacturer Narrative

The device has not been returned.Based on the information reported, including no identification of the relevant lot number, a relationship between the event and strattice cannot be determined.Strattice as a contributing factor cannot be ruled out.Multiple attempts were made to gather additional information; however to date, no further information has been obtained.The device was not returned for evaluation and the lot number remains unknown; therefore internal investigation into the event could not be performed.If additional information is reported, a follow up adverse event report will be submitted.No further actions are required as a nonconformance could not be confirmed.

Event Description

It was reported that a hernia patient had both a strattice and a synthetic mesh placed on (b)(6) 2018 recently had a recurrent seroma.First surgery the doctor placed strattice underlay and placed synthetic mesh overlay.Patient then developed a 1 liter seroma, so doctor took patient back to surgery to re-operate, removed only the synthetic mesh and saw that strattice was incorporated, so the strattice was not removed.Patient now has developed what they call a chronic seroma recurrence.

• Brand Name: UNKNOWN STRATTICE
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ 08876
• Manufacturer (Section G): LIFECELL; 1 millennium way; branchburg NJ 08876
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471100
• MDR Report Key: 8752983
• MDR Text Key: 149786074
• Report Number: 1000306051-2019-00094
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• PMA/PMN Number: K070560
• 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

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 Catalogue Number: UNK STRATTICE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2019
• Initial Date FDA Received: 07/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention