MAUDE Adverse Event Report: AMS/ENDO MONARCH SUBFACIAL SLING

Device Problems Degraded (1153); Flaked (1246)

Patient Problems Tissue Damage (2104); Toxicity (2333)

Event Date 12/23/2009

Event Type  Injury  

Event Description

Sui - medical mesh is just as dangerous in sling form.Polypropylene destroys body tissue and is toxic.Causing a whole host of terrible side effects.Stop poisoning women.

• Brand Name: MONARCH SUBFACIAL SLING
• Type of Device: MONARCH SUBFACIAL SLING
• Manufacturer (Section D): AMS/ENDO
• MDR Report Key: 3806941
• MDR Text Key: 4474920
• Report Number: MW5036041
• Device Sequence Number: 1
• Product Code: OTN
• 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: 04/30/2014

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: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/01/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 44 YR
• Patient Weight: 86