MAUDE Adverse Event Report: MPATHY MEDICAL POPMESH; SURGICAL MESH

Model Number CAL-PM1015

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

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

Event was reported to caldera medical by an attorney.Legal complaint states that the pt suffered serious and catastrophic bodily injuries, pain and suffering, general and special damages.The complaint also states that the pt suffered excruciating pain, laceration of and damage to internal bodily tissue and organs, erosion, abrasion and grating of internal bodily tissue and organs, dyspareunia, dysuria, severe edema, bleeding, permanent scarring, permanent bodily impairment and related sequelae.

• Brand Name: POPMESH
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): MPATHY MEDICAL; 1 lonmay road; 208 wright business centre; glasgow G334 EL; UK G334EL
• Manufacturer (Section G): CALDERA MEDICAL, INC.; 28632 roadside dr., suite 260; agoura hills CA 91301
• Manufacturer Contact: 28632 roadside dr., suite 260; agoura hills, CA 91301
• MDR Report Key: 4203519
• MDR Text Key: 18064372
• Report Number: 3003990090-2014-00024
• Device Sequence Number: 1
• Product Code: FTL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CAL-PM1015
• Device Catalogue Number: CAL-PM1015
• Device Lot Number: 19588-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/23/2014
• Distributor Facility Aware Date: 08/13/2013
• Event Location: Hospital
• Date Report to Manufacturer: 09/23/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention