MAUDE Adverse Event Report: UNKNOWN STRATTICE; MESH, SURGICAL

Catalog Number UNK STRATTICE

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

Patient Problems Erythema (1840); Seroma (2069); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

This event is being reported as serious injury due to the reported complications with surgical intervention.The lot associated with this event was not reported and remains unknown; therefore an internal investigation into the device history records could not be performed.No strattice devices were returned for evaluation.Based on the limited information, including no identification of the lot number, a relationship between the event and the strattice could not be determined.The nonincorporation was likely caused by the reported seroma, which can impact revascuralization.If additional information is received, a supplemental report will be submitted.

Event Description

It was reported from the field director of research learn execute who provided an ae form from project: "2022- absorbable synthetic mesh assessment in reconstruction / project id mraa-all-agna-220021/ cmops-ops-f-05-02" that reported "used to support a capsule and the product did not incorporate.May have developed seroma and a little red breast syndrome.When conducting revision surgery, noticed strattice was balled up in the corner of the pocket and did not incorporate.Removed strattice.Patient is doing fine.Was 7 ¿ 8 years ago" the patient was reported to be female and the ae form indicated the reporter does not attribute the event to the product and is willing to be contacted for follow up.The lot number was not reported and marked as "don't know".Therefore, the lot associated with this event is unknown.Additional information was received during follow up from the hcp who stated this case was a breast reconstruction case in 2012, at least 10 years ago, the lot is unknown, patient had no comorbidities, and the patient had red breast prior to surgery, complete separation of adm from capsule.The revision surgery was performed as there was a concern for mass on ct.The surgeon attributes the complications of red breast, seroma and non incorporation of adm to the device.

• Brand Name: UNKNOWN STRATTICE
• Type of Device: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 14990252
• MDR Text Key: 295728509
• Report Number: 1000306051-2022-00124
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• 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
• Date Manufacturer Received: 06/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sex: Female