MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PROGRIP; MESH, SURGICAL, POLYMERIC

Model Number	PP1509G
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Inflammation (1932); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, one day post-operatively on a right inguinal hernia repair procedure, the patient had severe cystitis.The patient received antibiotic treatment however it did not go away.The patient went to the urologist and the bladder was okay.When the surgeon performed ct scan it was found out that where the network is, that the surface of the bladder is always inflamed.Allergic reaction to the net.
Event or Problem Description
According to the reporter, one day post-operatively on a right inguinal hernia repair procedure, the patient had severe cystitis.The patient received antibiotic treatment however it did not go away.The patient went to the urologist and the bladder was okay.When the surgeon performed ct scan it was found out that where the network is, that the surface of the bladder is always inflamed.Allergic reaction to the net.Based on the results of the allergy test the patient was negative, that means the patient had no negative reaction related to the device.
Additional Manufacturer Narrative
Additional information: b5, g3, h6 correction: e1(first name, last name), e3, g4(pma/510(k)#) this event has been reassessed and found to be a non-mdr reportable complaint.The issue being reported is not associated with a serious injury or potential for serious injury with reoccurrence.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROGRIP
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 12164581
• Report Number: 9615742-2021-01692
• Device Sequence Number: 3704786
• Product Code: FTL
• UDI-Device Identifier: 10884521177635
• UDI-Public: 10884521177635
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K140941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2021

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: 06/30/2024
• Device Model Number: PP1509G
• Device Catalogue Number: PP1509G
• Device Lot Number: STG1390X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 08/10/2021
• 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: 80 YR
• Patient Weight: 64