MAUDE Adverse Event Report: ETHICON INC. ETHICON PHYSIOMESH COMPOSITE MESH 15X20CM OVAL; MESH, SURGICAL

Catalog Number PHY1520V

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Pain (1994); Hernia (2240); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

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.

Event Description

It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2010 and mesh was implanted.It was reported the patient experienced an unknown event.No additional information was provided.

Manufacturer Narrative

Date sent to the fda: 4/3/2022.H6: appropriate term / code not available (e2402) utilized to capture meshoma.Additional information: a2, b7, d1, d2a, d3, d4, d6b.Additional b5 narrative: it was reported that the patient underwent removal surgery on 8/3/2020 due to hernia recurrence and adhesion.It was reported that the patient experienced pain, meshoma.

Manufacturer Narrative

Date sent to the fda: 4/13/2022.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: ETHICON PHYSIOMESH COMPOSITE MESH 15X20CM OVAL
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• Manufacturer (Section G): ETHICON INC.-GMBH; p.o. box 1409; norderstedt D2284 1; GM D22841
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082182213
• MDR Report Key: 11092447
• MDR Text Key: 225539479
• Report Number: 2210968-2020-10395
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093932
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2011
• Device Catalogue Number: PHY1520V
• Device Lot Number: CJ9JMQZ0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female