MAUDE Adverse Event Report: ETHICON PROLEEN; MESH

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Arthritis (1723); Asthma (1726); Dyspnea (1816); Hernia (2240); Weight Changes (2607)

Event Date 01/04/2015

Event Type  Injury  

Event Description

Reporter stated that she had a full hysterectomy in 2011.One year later, she had a ventral hernia because the doctor did not do the hysterectomy well.On (b)(6) 2012 a second doctor repaired the hernia and mesh was implanted.On (b)(6) 2013 she had a triple hernia and was hospitalized.She is asthmatic and developed breathing complications at the hospital.Pig skin had to be put on her abdomen.Her appendix and gall bladder were removed.She has gained a lot of weight because of the pig skin and has to lose weight to be able to undergo another surgery.She has the 6th hernia now but the doctors would not do another surgery.The doctors insist that she walks to lose the weight.But she cannot because of arthritis.

• Brand Name: PROLEEN
• Type of Device: MESH
• Manufacturer (Section D): ETHICON
• MDR Report Key: 5147884
• MDR Text Key: 28346372
• Report Number: MW5056930
• Device Sequence Number: 1
• Product Code: FTL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Report Date: 10/07/2015

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
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/07/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 51 YR
• Patient Weight: 102