MAUDE Adverse Event Report: POLYPROPYLENE MARLEX MESH

Device Problems Migration or Expulsion of Device (1395); Device Operates Differently Than Expected (2913)

Patient Problems Muscle Weakness (1967); Neuropathy (1983); Pain (1994); Spinal Cord Injury (2432); Nervous System Injury (2689)

Event Date 05/07/1990

Event Type  Injury  

Event Description

Admitted to (b)(6) o.R.Obturator hernia repair, by military surgeon.Unk to me, implanted with polypropylene marlex mesh.Unable to wait for several months.Footdrop, muscle atrophy, and extreme pain.Civilian neurologist diagnosed sciatic nerve injury.No explanation given by surgeon, 6 months after surgery, emg and nerve conduction studies at (b)(6) confirmed injury to s1/s2, l4/l5, as well as obturator nerves.Much therapy, nerve blocks, meds.Unable to return to vocation (office clerical).Severe sciatic neuropathy, crps, etc., for nearly 27 years.Now more excruciating and debilitating pain with migration of mesh.

• Brand Name: POLYPROPYLENE MARLEX MESH
• Type of Device: POLYPROPYLENE MARLEX MESH
• MDR Report Key: 6345658
• MDR Text Key: 68035861
• Report Number: MW5067974
• 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
• Type of Report: Initial
• Report Date: 02/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: 81 MG ASPIRIN; BONE SUPPLEMENT; FISH OIL CAPSULE; MULTI-VITAMIN; PANTALOC
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 72 YR
• Patient Weight: 66