• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TUTOGEN MEDICAL, GMBH FORTIVA PORCINE, DERMIS Back to Search Results
Lot Number MP163501
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033); Impaired Healing (2378)
Event Date 12/04/2020
Event Type  Injury  
Manufacturer Narrative
Rti (b)(4) conducted a batch documentation review for serial id (b)(4) manufactured from lot mp163501. No departures were noted during processing. Serial id (b)(4), was manufactured to the specification detailed in (b)(4) "04"; annex 1-3 "05". The graft met all acceptance / inspection criteria prior to distribution. (b)(4). The vacuum assisted closure device was removed nine months post-operatively. Delayed wound healing can have many causes, (e. G. Injuries, surgeries, failure of blood supply, infection or radiation therapy. The patient did not have any confounding factors such as a special medical history, (b)(6) use, post-operative infection or immunosuppression. In general, hypersensitivity reactions to porcine collagen are a well known phenomenon and are described in the ifu of the fortiva product. However, since the patient's symptoms of an allergic reaction developed nine months post-operatively and only in one breast, it is more plausible that the adverse event is associated with a source or event extrinsic to the fortiva graft.
 
Event Description
(b)(6) and tutogen medical (b)(4) (tmi), a wholly subsidiary of (b)(6), received a complaint as part of the fortiva appear study. The complaint indicated that the patient underwent a bi-lateral breast reconstruction post mastectomy on (b)(6) 2020 with implantation of an rti fortiva graft. One silicon expander was implanted in her left breast. Two lymph nodes were removed and one drain remained indwelling. Nine months post-operatively, the patient developed a rash on (b)(6) 2020. The patient underwent removal of the left expander and placement of a new 250ml implant. On (b)(6) 2020, the patient underwent removal of the vacuum assisted closure device. On (b)(6) 2021, it was reported that the patient experienced delayed wound healing which was treated with antibiotics for prophylactic measures. The event resolved on (b)(6) 2021 with no residual effects. On 06/17/2021, information was provided to rti (b)(4) that the adverse event was procedure related and not device related. Follow-up information provided to rti (b)(4) on 09/14/2021, indicated that it is unknown if the patient's allergic reaction was related to the silicon implant or the fortiva graft.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFORTIVA
Type of DevicePORCINE, DERMIS
Manufacturer (Section D)
TUTOGEN MEDICAL, GMBH
industriestrasse 6
neunkirchen am brand
deu, germany 91077
GM 91077
MDR Report Key12601608
MDR Text Key284621153
Report Number3002924436-2021-00026
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 10/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2020
Device Lot NumberMP163501
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/08/2021 Patient Sequence Number: 1
-
-