MAUDE Adverse Event Report: UNKNOWN STRATTICE MESH, SURGICAL

Catalog Number UNK STRATTICE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bacterial Infection (1735); Capsular Contracture (1761)

Event Type  Injury  

Manufacturer Narrative

This mdr is being reported as a multiple events type for serious injury with an abundance of caution. There is no confirmation of the possible relationship the strattice. The corresponding author has not provided additional clinical information. The device was not returned for evaluation and the lot numbers remain unknown; therefore, internal investigation into the event could not be performed. Based on the reported information, a relationship between the event and strattice cannot be determined. 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

The impact of premastectomy versus postmastectomy radiation therapy on outcomes in prepectoral implant-based breast reconstruction author catherine sinnott, general surgeon a literature publication from a retrospective chart review in the u. S. On the use of strattice in prepectoral implant-based breast reconstruction. Strattice was used in all 592 reconstructions. The purpose of the study was to compare complication rates for patients who received pre-mastectomy radiation treatment to patients who received post-mastectomy radiation treatment to patients who received no radiation treatment. The conclusion determined that in prepectoral implant breast reconstruction, premastectomy and postmastectomy radiation therapy were associated with higher rates of infection and implant loss compared with nonradiated patients. Postmastectomy radiation was associated with a higher rate of capsular contracture compared with nonradiated. Article is attached.

• Brand Name: UNKNOWN STRATTICE
• Type of Device: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 12058132
• MDR Text Key: 258426906
• Report Number: 1000306051-2021-03020
• 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: literature

Reporter Occupation

• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK STRATTICE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/26/2021
• 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 Treatment Data

Date Received: 06/24/2021 Patient Sequence Number: 1