MAUDE Adverse Event Report: SOFRADIM PRODUCTION PARIETEX PCOX RND 9CM X1

Model Number PCO9X

Device Problem Material Frayed (1262)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Description of event or complaint: "opened onto field for dr.Griffin.He went to put a stitch through it and he said he couldn't use because it was fraying around the edges.".

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

• Brand Name: PARIETEX PCOX RND 9CM X1
• Type of Device: PARIETEX PCOX
• Manufacturer (Section D): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux ; FR
• Manufacturer (Section G): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux ; FR
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06743 ; 2034925267
• MDR Report Key: 4166157
• MDR Text Key: 4870033
• Report Number: 9615742-2014-00318
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PCO9X
• Device Catalogue Number: PCO9X
• Device Lot Number: PNI0181X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other