MAUDE Adverse Event Report: ETHICON INC. PRLNE 3D PATCH MED DIAMOND (3.5CM); MESH, SURGICAL, POLYMERIC

Catalog Number	P3DPM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Pain (1994); Sepsis (2067)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.In addition, a review of the manufacturing records was performed and indicates that there were no quality concerns associated with the manufacturing process.
Event or Problem Description
It was reported by an attorney the patient that post-op of a hernia repair, the mesh was defective and it 'darn near killed me.' she said 'it never felt right' following implant on (b)(6) 2012.Her symptoms included constipation and pain.In (b)(6) 2019 she presented with fever and was diagnosed as septic.She had a colostomy for six weeks and daily antibiotic infusions prior to surgery on (b)(6) 2019.She stated she had been in hospital four times for this.In surgery it was discovered the plug came out, the mesh had broken up and dispersed throughout her abdomen.Five inches of colon were removed as was the mesh implant.She still has an open wound, but it is healing.She is afebrile currently.Patient has given permission to contact her surgeon, and stated she will be contacting an attorney.No additional information was provided.

• Brand Name: PRLNE 3D PATCH MED DIAMOND (3.5CM)
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): J-PAC; 25 centered; nh; somersworth 03878
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 9068526
• Report Number: 2210968-2019-86693
• Device Sequence Number: 3587975
• Product Code: FTL
• UDI-Device Identifier: 10705031047525
• UDI-Public: 10705031047525
• Combination Product (Y/N): N
• PMA/510(K) Number: K010722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/03/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: P3DPM
• Device Lot Number: 26009-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 09/03/2019; 09/03/2019; 09/03/2019
• Initial Report FDA Received Date: 09/15/2019
• Supplement Report FDA Received Date: 03/29/2024; 03/29/2024; 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2012
• 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 Age: 74 YR
• Patient Sex: Female