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 Hernia (2240)

Event Date 12/15/2019

Event Type  Injury  

Manufacturer Narrative

Laboratory analysis: the complaint related graft was returned in a clin pack, inside a specimen container with saline.The sample was forwarded to the histology department for further analysis.Further information regarding event, product, or patient details has been requested.No additional information is available at this time.

Event Description

Company representative reports incisional hernia repair with strattice.4 months later, patient noticed a gradually enlarging bulge.Strattice was not incorporated/floppy.Cat scan verified recurrence.Removed mesh and repaired incisional hernia with new piece of strattice.Patient is "stable, recovering well.".

• 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: brent livingstone ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 10936590
• MDR Text Key: 219314738
• Report Number: 1000306051-2020-00055
• 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

• Date FDA Received: 12/02/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention
• Patient Age: 60 YR