MAUDE Adverse Event Report: TEI BIOSCIENCE INC. / INTEGRA LIFESCIENCES SURGIMEND; COLLAGEN MATRIX FOR SOFT TISSUE

Model Number 606-400-016

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Impaired Healing (2378)

Event Date 09/28/2016

Event Type  Injury  

Event Description

Use surgimend (collagen matrix for soft tissue reconstruction), 3 cases out of 4 caused delay wound healing and patients returned to operating room for interventions.All 4 cases were done by different surgeons.We cannot attribute a cause and effect relationship but our surgeons have decided to stop using the product.Date of procedure: (b)(6) 2016; surgimend; model: surgimend ref 606-400-009; lot number: 1511004; serial number: none; provisional diagnosis: erosion of other implanted mesh and other prosthetic materials to surrounding.Date of procedure: (b)(6) 2016; surgimend; model: surgimend ref 606-400-016; size 25cm x 40cm; lot number: 1601020; serial number: none.Provisional diag: unspecified abdominal hernia without obstruction or gangrene.Date of procedure: (b)(6) 2016; surgimend, model: surgimend ref 606-400-009; size 13cm x 25cm; lot number: 1608015; serial number: none.Provisional diag: ventral hernia without obstruction of gangrene.Reference report numbers: mw5068786 and mw5068787.

• Brand Name: SURGIMEND
• Type of Device: COLLAGEN MATRIX FOR SOFT TISSUE
• Manufacturer (Section D): TEI BIOSCIENCE INC. / INTEGRA LIFESCIENCES
• MDR Report Key: 6450404
• MDR Text Key: 71684310
• Report Number: MW5068785
• Device Sequence Number: 1
• Product Code: FTM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 606-400-016
• Device Lot Number: 1601020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention