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

Catalog Number 606-004-100

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Seroma (2069); Injury (2348); Tissue Breakdown (2681)

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 the patient presented 2 weeks postoperatively with a mild wound breakdown medially to lateral incision, lateral to the areola.A 2-3mm opening resulting in excessive amounts of clear yellow fluid ¿seroma¿.On exploration surgimend was found to be ¿stretching¿ or degrading at the fenestrations sub-dermal to the site of wound breakdown.Nothing grown in culture.Treated with antibiotics and cleaned out using betadine.

Manufacturer Narrative

Integra has completed their internal investigation on february 15, 2018.Results: unable to conduct failure analysis and root cause due to product not being returned (implanted in patient) dhr review; no abnormalities were found and all manufacturing related process steps were followed and documented per listed instructions and current good manufacturing practices.Complaints history; a query of the trackwise complaints database for the timeframe of 10jan2017 ¿ 10jan2018 was performed using the keywords: ¿surgimend,¿ ¿degraded, ¿ and ¿degrading¿ this is the only complaint related to ¿surgimend ¿ degrading".(b)(4).

Manufacturer Narrative

The failure is unconfirmed and failure analysis could not be performed as the product has not been returned (still implanted in the patient).If product is returned at a later date, the complaint investigation will be updated as applicable.Root cause is indeterminable.The device was not returned for failure analysis as it remains implanted in the patient (per complaint documentation).There were no anomalies found in the dhr review.Based on the dhr review conducted, there is no indication that the manufacturing 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: 7219516
• MDR Text Key: 98242130
• Report Number: 3004170064-2018-00001
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• PMA/PMN Number: K083898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 606-004-100
• Device Lot Number: 1511007
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other