MAUDE Adverse Event Report: TEPHA, INC. - 3005670760 GALAFLEX; ABSORBABLE MESH

Catalog Number	UNKAA128
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Hematoma (1884); Burning Sensation (2146); Deformity/ Disfigurement (2360); Breast Discomfort/Pain (4504)
Date of Event	09/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported the patient underwent a revision procedure due to a failed breast lift the "pocket was excessively large" and at that time was implanted with a galaflex scaffold.Following the revision procedure, it is alleged that the patient¿s breast is deformed and there is a burning sensation.It is unclear what additional postoperative adverse outcomes the contacted is alleging.The information provided is limited and there has been no response to date from requests for additional information.Based on the information provided, we are unable to determine the extent to which the implant may have caused of contributed to the alleged post implant symptoms.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of event ((b)(6) 2023) is considered to be a best estimated.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : not returned.
Event or Problem Description
As reported "i am one of the unfortunate people who is suffering from literally every complication listed on the possible adverse events from galaflex.I had a failed breast lift and the pocket was excessively large.The surgeon determined that galaflex would be a good option to repair the pocket.When i researched the possible problems, i found i didn't miss a reaction.I am in real trouble and am checking to see if you offer any assistance in the removal my surgeon said i need, just a month out of surgery and the subsequent repair i am going to need? the only thing i don't have is recurrence.The extrusion and dehiscence is just around the corner.Is just around the corner with the incision thinning more each day.The deformity is gross.I had a breast mri yesterday and i will see the extent of damage.The breast burns like a chemical was in it that is caustic.I am not sure about the migration.Adverse reactions possible complications include infection, seroma, pain, scaffold migration, wound dehiscence, hemorrhage, adhesions, hematoma, inflammation, extrusion and recurrence of the soft tissue defect.".
Additional Manufacturer Narrative
As reported the patient underwent a revision procedure due to a failed breast lift the "pocket was excessively large" and at that time was implanted with a galaflex scaffold.Following the revision procedure, it is alleged that the patient¿s breast is deformed and there is a burning sensation.It is unclear what additional postoperative adverse outcomes the contacted is alleging.The information provided is limited and there has been no response to date from requests for additional information.Based on the information provided, we are unable to determine the extent to which the implant may have caused of contributed to the alleged post implant symptoms.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of event (28-sep-2023) is considered to be a best estimated.Addendum: this supplemental mdr is submitted to document additional information received.It was additionally reported that the patient was diagnosed with hematoma thereby underwent explant surgery.Based on the information provided, no conclusions can be made.The adverse reaction section of the instructions-for-use, supplied with the device identify hematoma as a possible complication.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text: not returned.
Event or Problem Description
As reported "i am one of the unfortunate people who is suffering from literally every complication listed on the possible adverse events from galaflex.I had a failed breast lift and the pocket was excessively large.The surgeon determined that galaflex would be a good option to repair the pocket.When i researched the possible problems, i found i didn't miss a reaction.I am in real trouble and am checking to see if you offer any assistance in the removal my surgeon said i need, just a month out of surgery and the subsequent repair i am going to need? the only thing i don't have is recurrence.The extrusion and dehiscence is just around the corner.Is just around the corner with the incision thinning more each day.The deformity is gross.I had a breast mri yesterday and i will see the extent of damage.The breast burns like a chemical was in it that is caustic.I am not sure about the migration.Adverse reactions possible complications include infection, seroma, pain, scaffold migration, wound dehiscence, hemorrhage, adhesions, hematoma, inflammation, extrusion and recurrence of the soft tissue defect." addendum per additional information: it was reported that the patient had large hematoma under the mesh thereby underwent emergency surgery with mesh removal.

• Brand Name: GALAFLEX
• Common Device Name: ABSORBABLE MESH
• Manufacturer (Section D): TEPHA, INC. - 3005670760; 99 hayden ave suite 360; lexington MA 02421
• Manufacturer (Section G): TEPHA, INC. - 3005670760; 99 hayden ave suite 360; lexington MA 02421
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 17981535
• Report Number: 1213643-2023-00385
• Device Sequence Number: 12611600
• Product Code: OOD
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K140533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: UNKAA128
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2023
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female