MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE SUTURE; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number 8698G

Device Problem Reaction (1514)

Patient Problems Reaction (2414); Treatment with medication(s) (2571)

Event Type  Injury  

Event Description

It was reported that a patient underwent a skin closure procedure on an unknown date and suture was used for two layer suturing.The patient experienced redness and burning.The patient had topical steroids applied to the area.Additional information was requested.

Manufacturer Narrative

(b)(4).Conclusion: to date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.Additional information: the actual device batch number associated with this event is not known.Two possible batch numbers are reported as follows: batch gjb938; batch gln535.In addition, a review of the batch manufacturing records for the possible batch number gjb938 was conducted and the batch met all finished goods release criteria.

Manufacturer Narrative

(b)(4).The actual device batch number associated with this event is not known.Two possible batch numbers are reported as follows: batch gjb938; batch glb535.In addition, a review of the batch manufacturing records for the possible batch numbers were conducted and the batches met all finished goods release criteria.

• Brand Name: PROLENE POLYPROPYLENE SUTURE
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 015
• Manufacturer (Section G): UNKNOWN; unknown; x
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 3634580
• MDR Text Key: 3989188
• Report Number: 2210968-2014-01647
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8698G
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention