MAUDE Adverse Event Report: TEI BIOSCIENCES INC SURGIMEND 3.0 13X25 CM

Catalog Number 606-300-009

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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.

Event Description

A sales representative reported that surgimend (id (b)(6)) dissolved after implantation.No patient injury reported.No additional information was provided after several attempts.

• Brand Name: SURGIMEND 3.0 13X25 CM
• Type of Device: SURGIMEND
• Manufacturer (Section D): TEI BIOSCIENCES INC; 7 elkins street; 7 elkins street; boston MA 02127
• Manufacturer (Section G): TEI BIOSCIENCES INC; 7 elkins street; boston MA 02127
• Manufacturer Contact: vivian nelson ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 8431932
• MDR Text Key: 139181680
• Report Number: 3004170064-2019-00007
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 606-300-009
• Device Lot Number: 1804009
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/08/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1