MAUDE Adverse Event Report: TEI BIOSCIENCES INC SURGIMEND PRS 10CM X 15CM SEMI

Catalog Number 606-004-100

Device Problem Insufficient Information (3190)

Patient Problems Edema (1820); Necrosis (1971)

Event Type  Injury  

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.

Event Description

It was reported that on (b)(6) 2018, medical team performed a breast reconstruction under the muscle with surgimend.Initially the patient had completely unstressed wounds and tissue.Bleeding appeared.After about five days, the patient developed a massive edema blistering with necrosis in the area where the adm is located.The patient is currently under antibiotics and cortisone and the medical team is not sure if the prosthesis is already infected.Additional information has been requested.

Manufacturer Narrative

Additional information received : comments from surgeon : "the patient had a toxic reaction and, skin flap infection and partial necrosis.Meanwhile it healed with massive scaring and contraction, but the patient is complaining about the unpleasant aesthetic result.".

Event Description

N/a.

Manufacturer Narrative

Additional information received: "the patient is doing better and returned to work.The left breast is still swollen, the necrotic area reepithelised with scar.Patient was born 1969.Later we have to do some scar corrections and lipofilling.".

Manufacturer Narrative

Root cause is indeterminable.The device was not returned for failure analysis.There were no anomalies found in the dhr review.Based on the dhr review conducted, there is no indication that the manufacturing or final packaging/labeling processes may have contributed to this complaint.Additionally, all finished goods lots released to the market by integra lifesciences meet raw material, in-process and finished goods release acceptance criteria for all required inspections and tests.

• Brand Name: SURGIMEND PRS 10CM X 15CM SEMI
• Type of Device: SURGIMEND
• Manufacturer (Section D): TEI BIOSCIENCES INC; 7 elkins street; 7 elkins street; boston MA 02127
• MDR Report Key: 8253004
• MDR Text Key: 133223778
• Report Number: 3004170064-2019-00006
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• PMA/PMN Number: K071807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/03/2019

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 Catalogue Number: 606-004-100
• Device Lot Number: 1806004
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/03/2019
• Initial Date FDA Received: 01/16/2019
• Supplement Dates Manufacturer Received: 01/30/2019; 01/31/2019; 05/13/2019
• Supplement Dates FDA Received: 01/30/2019; 01/31/2019; 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR