MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS UGYTEX; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR

Model Number UGYKA

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 11/29/2007

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Alleged claim reported in (b)(6) (pending on translation) it is reported by the lawyer that a patient injury occurred after the device was implanted ((b)(6) 2007).Device was used for therapeutic treatment.

• Brand Name: UGYTEX
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer (Section G): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 12122234
• MDR Text Key: 260080493
• Report Number: 9615742-2021-01672
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K051503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/06/2021

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: Health Professional
• Device Model Number: UGYKA
• Device Catalogue Number: UGYKA
• Device Lot Number: ZHI00366
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/10/2021
• Initial Date FDA Received: 07/06/2021
• 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): Life Threatening
• Patient Age: 28 YR