MAUDE Adverse Event Report: SOFRADIM PRODUCTION PARIETENE PROGRIP PPL/PLA 15X9CM

Model Number PP1509G

Device Problem Failure To Adhere Or Bond (1031)

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

Event Type  Injury  

Event Description

According to the reporter: the reporting person said, the screen has not adhered to the tissue.No injury reported.No permanent damage.The event did not prolong the hospital stay.There was no bleeding in excess.The surgical time was not extended.The event did not prolong the hospital stay.Additional information requested via email.When was this issue noticed? was any additional fixation methods utilized? i.If so, what? 3.How was it corrected? 4.How is the patient currently? the customer doesn't have these informations.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

• Brand Name: PARIETENE PROGRIP PPL/PLA 15X9CM
• Type of Device: PARIETENE PROGRIP
• 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 avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 4109255
• MDR Text Key: 4839441
• Report Number: 9615742-2014-00300
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/05/2014

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: Health Professional
• Device Model Number: PP1509G
• Device Catalogue Number: PP1509G
• Device Lot Number: SJI00326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/05/2014
• Initial Date FDA Received: 09/23/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/12/2014; 05/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other