MAUDE Adverse Event Report: TEI BIOSCIENCES INC SURGIMEND PRS MESHED 20CM X 10CM X 1MM INTL

Catalog Number 606-907-001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

Patient 1: a facility reported the surgeon used surgimend and patient developed hypersensibility (skin seemed to be irritated, erythema).It appeared once and it was continuous for about three weeks.Surgimend was used for pectoral breast reconstruction.Additional information has been requested.1 of 6 reports: same adverse event, different patients.Other mfg report numbers: 3004170064-2020-00012, 3004170064-2020-00013, 3004170064-2020-00014, 3004170064-2020-00015, and 3004170064-2020-00016.

Manufacturer Narrative

Surgimend was not returned for evaluation (remains implanted); therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

N/a.

• Brand Name: SURGIMEND PRS MESHED 20CM X 10CM X 1MM INTL
• Type of Device: SURGIMEND
• Manufacturer (Section D): TEI BIOSCIENCES INC; 7 elkins street; 7 elkins street; boston MA 02127
• MDR Report Key: 10826180
• MDR Text Key: 215891763
• Report Number: 3004170064-2020-00011
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• PMA/PMN Number: K171357
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 03/26/2021

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 Expiration Date: 02/29/2024
• Device Catalogue Number: 606-907-001
• Device Lot Number: 1904004
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 11/11/2020
• Supplement Dates Manufacturer Received: 03/24/2021
• Supplement Dates FDA Received: 03/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1