MAUDE Adverse Event Report: ETHICON INC. ETHICON PHYSIOMESH OPEN 12 X 15CM; MESH, SURGICAL, POLYMERIC

Model Number OPHY1215

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

Patient Problems Diarrhea (1811); Hypersensitivity/Allergic reaction (1907); Pain (1994); Cramp(s) /Muscle Spasm(s) (4521)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc., 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.(b)(4) - device not returned attempts are being made to obtain the following information. to date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? if so, please provide your surgeon¿s name, contact information and sign release of medical information form attached.

Event Description

It was reported that a patient underwent an unknown procedure on an unknown date three years ago and the mesh was implanted.It was reported that since the mesh insertion, the patient has been diagnosed with alpha gal syndrome.It was reported that the patient experiences allergic reaction.It was also reported that every time the patient eats, the patient gets abdominal cramps and it's so painful that the patient has to sit on the toilet in case the patient has diarrhea.Additional information has been requested.

• Brand Name: ETHICON PHYSIOMESH OPEN 12 X 15CM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; p.o. box 1409; norderstedt 22841 ; GM 22841
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15386452
• MDR Text Key: 299554187
• Report Number: 2210968-2022-07384
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031233188
• UDI-Public: 10705031233188
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OPHY1215
• Device Catalogue Number: OPHY1215
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male