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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TUTOGEN MEDICAL GMBH FORTIVA PORCINE DERMIS PORCINE DERMIS GRAFT, PRODUCT CODE FTM

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TUTOGEN MEDICAL GMBH FORTIVA PORCINE DERMIS PORCINE DERMIS GRAFT, PRODUCT CODE FTM Back to Search Results
Lot Number PD18100001
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Hypersensitivity/Allergic reaction (1907); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 11/18/2020
Event Type  Injury  
Manufacturer Narrative
At this time the investigation is pending a comprehensive records review. When the information is provided a follow-up will be submitted.
 
Event Description
Rti surgical, inc (rti) and tutogen medical gmbh (tmi), a wholly owned subsidiary of rti, received a complaint as part of the fortiva appear trial. The reported complaint indicated that a patient underwent a left breast reconstruction with implantation of a fortiva porcine dermis graft and a silicone implant on (b)(6) 2019. The patient developed nipple necrosis to the left breast requiring surgical debridement on (b)(6) 2020. She was treated with antibiotics. The affected area continued to break down leading to dehiscence on (b)(6) 2020. On (b)(6) 2020, further nipple debridement was performed, as well as removal of the silicone implant and changed to a tissue expander. The fortiva xenograft remains implanted. The patient was discharged on (b)(6) 2020 (a med watch was submitted reference to the intial event reference med watch # (b)(4). On b)(6) 2021, additional information was received (serial id# b)(4), lot# pd18100001) that reported ongoing "bunching and hardening" of the matrix in the left breast, which the surgeon made an effort to reduce but some still remains. The patient is awaiting fat grafting to also help with this.
 
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Brand NameFORTIVA PORCINE DERMIS
Type of DevicePORCINE DERMIS GRAFT, PRODUCT CODE FTM
Manufacturer (Section D)
TUTOGEN MEDICAL GMBH
industriestrabe 6
neunkirchen am brand, germany 97077
GM 97077
Manufacturer (Section G)
RTI SURGICAL, INC
11621 research circle
alachua FL 32615
Manufacturer Contact
charity emmons
11621 research circle
alachua, FL 32615
3864188888
MDR Report Key13112373
MDR Text Key284375605
Report Number3002924436-2021-00036
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142070
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Expiration Date10/31/2021
Device Lot NumberPD18100001
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/03/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/30/2018
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: 12/29/2021 Patient Sequence Number: 1
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