MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN SURGIPRO; MESH, SURGICAL, POLYMERIC

Model Number	SPMM-46
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hernia (2240); Injury (2348)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
To date, the incident sample has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.The patient underwent a hernia repair with mesh.
Additional Manufacturer Narrative
This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a hernia.It was reported that after implant, the patient experienced a recurrent ventral hernia.Post-operative patient treatment included repair of recurrent ventral hernia with mesh and previous mesh excised.(b)(6) 2016 - recurrent ventral hernia treated with bard flat 3x6.(b)(6) 2019 - recurrent ventral hernia treated with bard 15x15.
Additional Manufacturer Narrative
This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a ventral hernia.It was reported that after implant, the patient experienced a recurrent ventral hernia.Post-operative patient treatment included repair of recurrent ventral hernia with mesh and previous mesh excised.On (b)(6) 2016 - recurrent ventral hernia treated with bard flat 3x6 30.On (b)(6) 2019 - recurrent ventral hernia treated with bard 15x15.

• Brand Name: SURGIPRO
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7111790
• Report Number: 1219930-2017-09891
• Device Sequence Number: 13815716
• Product Code: FTL
• UDI-Device Identifier: 10884521101432
• UDI-Public: 10884521101432
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K915526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: SPMM-46
• Device Catalogue Number: SPMM-46
• Device Lot Number: A5C1465X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/14/2017
• Supplement Date Received by Manufacturer: 05/15/2019; 05/15/2019
• Initial Report FDA Received Date: 12/13/2017
• Supplement Report FDA Received Date: 08/22/2019; 09/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Weight: 70