MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE SUTURE; SUTURES - NON-ABSORBABLE

Catalog Number 8687H

Device Problem Reaction (1514)

Patient Problems Pain (1994); Swelling (2091); Surgical procedure (2357); Reaction (2414); Treatment with medication(s) (2571)

Event Date 12/09/2013

Event Type  Injury  

Event Description

It was reported by the patient she underwent a biopsy about one month ago that did not require suturing.When the results came back, more tissue needed to be removed.On (b)(6) 2013, the patient underwent a procedure to remove a non-cancerous spot and suture was used.The patient experienced pain and swelling across her chest.The patient went back to the office after a few hours.The surgeon told the patient she had a reaction to the suture and removed the suture from the middle of the area without resuturing the area.Other suture materials were used to complete the procedure.Mupirocin ointment was prescribed.Currently, the patient still has pain, itching and soreness.

Manufacturer Narrative

(b)(4).In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Manufacturer Narrative

(b)(4).Conclusion: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.

• Brand Name: PROLENE POLYPROPYLENE SUTURE
• Type of Device: SUTURES - NON-ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 015
• Manufacturer (Section G): ETHICON INC. - SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR 0075 4
• Manufacturer Contact: kathy rice ; 4545 creek rd; cincinnati, OH 45242-2803 ; 5133373299
• MDR Report Key: 3557799
• MDR Text Key: 4049560
• Report Number: 2210968-2014-00133
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N16374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/18/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8687H
• Device Lot Number: EHP140
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2014
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention