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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TEI BIOSCIENCES INC SURGIMEND 2.0 5X6 CM

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TEI BIOSCIENCES INC SURGIMEND 2.0 5X6 CM Back to Search Results
Catalog Number 606-200-002
Device Problems Device Expiration Issue (1216); Improper or Incorrect Procedure or Method (2017)
Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Date 02/02/2016
Event Type  Injury  
Event Description
It was reported a piece of expired (hospital owned) product was implanted. A field representative got a call from a hospital operations manager who noted they had implanted the product in a patient on (b)(6) 2016, but observed records that the product was labeled as expired dec2015. A check of the lot number confirmed the product was shipped 8oct2015, within company policy for shipping product. It was later reported the product remains implanted. It is not believed that the patient was injured.
 
Manufacturer Narrative
Additional information received via phone call from customer contact 9mar2016: the patient is doing very well. There are no additional procedures planned, no plan to remove the product. Integra completed its internal investigation 2 march2016. The investigation included: methods: dhr review, complaint review. Results: dhr review was performed for lot #1202062 on 02mar2016. Everything is within the product specifications and no anomalies were found. This event is not adversely trending. There have been no similar events where an expired product was implanted in the last 12 months. The product remains implanted in the patient; therefore, a failure analysis is not possible.
 
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Brand NameSURGIMEND 2.0 5X6 CM
Type of DeviceSURGIMEND
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
maria leonard
311 enterprise drive
plainsboro, NJ 08536
6099362393
MDR Report Key5460945
MDR Text Key39045700
Report Number3004170064-2016-00001
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
K083898
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/04/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number606-200-002
Device Lot Number1202062
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/02/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/05/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/25/2016 Patient Sequence Number: 1
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