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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TUTOGEN MEDICAL, GMBH FORTIVA PORCINE DERMIS SURGICAL MESH

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TUTOGEN MEDICAL, GMBH FORTIVA PORCINE DERMIS SURGICAL MESH Back to Search Results
Lot Number MP163601
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Local Reaction (2035); Seroma (2069); Breast Discomfort/Pain (4504); Skin Inflammation/ Irritation (4545)
Event Date 05/22/2021
Event Type  Injury  
Manufacturer Narrative
Rti (b)(4) conducted a batch documentation review for serial id (b)(4) manufactured from lot mp163601. No departures from standard operating procedures were noted during the records re-review that would negatively impact the manufacturing of porcine dermis xenografts from the lot. Manufacturing records review indicated that serial id (b)(4) met all acceptance / inspection criteria prior to distribution. To date, rti (b)(4) has manufactured and distributed (b)(4) fortiva dermis grafts from the lot without related complaints. The development of red breast syndrome is a well known phenomenon following breast reconstruction after mastectomy with fortiva graft implanted. However, red breast syndrome may also be triggered by a seroma, hematoma, infection, radiation, vascular insufficiency and hypersensitivity reactions to specific materials. The patient developed red breast syndrome approximately 10 months post-operatively. It is more plausible that the patient's adverse event was associated with a source or event extrinsic to the xenograft implant.
 
Event Description
Rti surgical, inc. And tutogen medical (b)(4), a wholly subsidiary of rti surgical, received a complaint as part of the fortiva appear trial. The reported complaint indicated that on (b)(6) 2020, the patient underwent a nipple conserving inframammary left and right mastectomy. Five lymph nodes were removed from the right side. No lymph nodes were removed on the left side. The patient underwent a bilateral breast reconstruction with implantation of two fortiva grafts and two silicone implants. Three drains were placed. One drain was removed on (b)(6) 2020 and the other two drains were removed on (b)(6) 2020. On (b)(6) 2021, approximately 10 months post-operatively, the patient developed bilateral red breast syndrome, pain and bilateral seromas that resolved on (b)(6) 2021. She was treated with clindamycin 600mg on (b)(6) 2021. She underwent seroma punctures on (b)(6) 2021. The seromas resolved on (b)(6) 2021 with no residual effects. In early (b)(6) 2021, the patient received a covid vaccination. Her symptoms following the vaccination consisted of redness, swelling, pain in her breasts, restricted movement of her arms and pain in her limbs. On (b)(6) 2021, the patient was treated with paracetamol for 3-4 days. Her symptoms resolved with no residual effects.
 
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Brand NameFORTIVA PORCINE DERMIS
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
TUTOGEN MEDICAL, GMBH
industriestrasse 6
neunkirchen am brand, deu 91077
GM 91077
MDR Report Key12724106
MDR Text Key282343563
Report Number3002924436-2021-00032
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
K142070
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial
Report Date 10/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2021
Device Lot NumberMP163601
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/30/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/29/2021 Patient Sequence Number: 1
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