MAUDE Adverse Event Report: ETHICON INC. PROLENE* POLYPROPYLENE MESH; MESH, SURGICAL, POLYMERIC

Catalog Number	PML
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Abscess (1690); High Blood Pressure/ Hypertension (1908); Inflammation (1932); Hernia (2240); Post Operative Wound Infection (2446); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
I was in my kitchen sitting on the seat of my drive medical walker and it broke.This is the second time i've had an issue with a drive walker breaking in exactly the same spot.The first time i was able to grab a hold of the counter and not fall.This time i fell to the floor and was injured.Paramedics had to come and get me up.I have a huge bruise on my arm and internally i pulled muscles that have been painful the entire week.I did contact (b)(6) because the walker brought in exactly the same spot both times.It seems as though if i have had two walkers out of five that i've owned break that this must be a major issue.I was fortunate to not break a limb, or hit my head, but had i been outside or elsewhere i don't know what would've happened.I think that needs to be looked into.I have a picture of my visible injuries as well as the broken walker if you would like to see it.Ref report: mw5158894.
Additional Manufacturer Narrative
Date sent to the fda: 9/13/2024.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20113696
• Report Number: 2210968-2024-09196
• Device Sequence Number: 6968768
• Product Code: FTL
• UDI-Device Identifier: 10705031049031
• UDI-Public: (01)10705031049031(17)130731(10)AKP955
• Combination Product (Y/N): N
• Initial Reporter Country: ZI
• PMA/510(K) Number: K180829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2024

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: 07/31/2013
• Device Catalogue Number: PML
• Device Lot Number: AKP955
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/21/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 08/30/2024
• Supplement Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2008
• 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