MAUDE Adverse Event Report: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 16 X 20, FIRM; MESH, SURGICAL

Catalog Number	1620002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	04/03/2012
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through a legal event that a female patient underwent hernia repair surgery on or about (b)(6) 2008.During the hernia repair surgery, the surgeon implanted a strattice firm mesh in her.The lot number for that mesh is s1d088, catalog number for that mesh is 1620002.After surgery, the patient returned to the hospital on or about (b)(6) 2012 with complaints of abdominal pain.She was diagnosed with recurrent incisional hernia.On or about (b)(6) 2012 she underwent a revision surgery for repair of recurrent incisional hernia with mesh and removal of foreign body, which was the previously placed strattice mesh.During the procedure, her surgeon noted multiple intra-abdominal adhesions between the omentum and anterior abdominal wall, fascial defect, and totally dislodged the old mesh which was dissected off.It should be noted the lot number provided is not populating as a valid lot, therefore, the lot associated with this event is unknown.The catalog/item number is valid.
Additional Manufacturer Narrative
This legal event is being reported as serious injury due to the reported recurrence with surgical intervention.The lot associated with this event was not reported and remains unknown; therefore a review of the device history records could not be performed.No strattice devices were returned for evaluation.Based on the limited information reported, a relationship between the event and strattice cannot be confirmed.Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.
Event or Problem Description
This is follow up#1 to report on 8/24/2022, pmqa received follow up notification from legal that the lot associated with this event was found through discovery and is s1d086-010.However, the lot number provided is an invalid lot number, therefore, the lot associated with this event remains unknown.As reported in the initial: initial it was reported through a legal event that a female patient underwent hernia repair surgery on or about (b)(6) 2008.During the hernia repair surgery, the surgeon implanted a strattice firm mesh in her.The lot number for that mesh is s1d088, catalog number for that mesh is 1620002.After surgery, the patient returned to the hospital on or about (b)(6) 2012 with complaints of abdominal pain.She was diagnosed with recurrent incisional hernia.On or about (b)(6) 2012 she underwent a revision surgery for repair of recurrent incisional hernia with mesh and removal of foreign body, which was the previously placed strattice mesh.During the procedure, her surgeon noted multiple intra-abdominal adhesions between the omentum and anterior abdominal wall, fascial defect, and totally dislodged the old mesh which was dissected off.It should be noted the lot number provided is not populating as a valid lot, therefore, the lot associated with this event is unknown.The catalog/item number is valid.
Additional Manufacturer Narrative
Additional and/or corrected data: b5, h10 the lot number associated with this event was found through discovery and is s1d086-010.However, the lot number provided is an invalid lot number, therefore, the lot associated with this event remains unknown and the investigation conclusion remains unchanged.Based on the limited information reported, a relationship between the event and strattice cannot be confirmed.As reported in the initial: this legal event is being reported as serious injury due to the reported recurrence with surgical intervention.The lot associated with this event was not reported and remains unknown; therefore a review of the device history records could not be performed.No strattice devices were returned for evaluation.Based on the limited information reported, a relationship between the event and strattice cannot be confirmed.Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 16 X 20, FIRM
• Common Device Name: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 14274156
• Report Number: 1000306051-2022-00079
• Device Sequence Number: 20043991
• Product Code: FTM
• UDI-Device Identifier: 00818410010010
• UDI-Public: 00818410010010
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K070560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2012
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2022

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: 1620002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2022
• Supplement Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 08/25/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NO INFORMATION REPORTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female