MAUDE Adverse Event Report: ETHICON INC. SURGICAL GUT SUTURE -PLAIN; SUTURE, ABSORBABLE, NATURAL

Catalog Number 1915G

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem Wound Dehiscence (1154)

Event Type  Injury  

Manufacturer Narrative

Conclusion: representative samples were returned for evaluation.They were visually and functionally examined for tensile strength and they met the requirements.

Event Description

It was reported that a patient underwent a blepharoplasty procedure on an unknown date and suture was used.The patient experienced the wound opening several days after the surgery.It is unknown how the patient was treated.The customer questioned whether the suture is still fast absorbing because the label does not state fast absorbing.Additional information was requested.

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

Manufacturer Narrative

Recall: z-1839-2015.Conclusion: representative samples were received for evaluation.Visual inspection found the information in the packet was not complete.The product is fast absorbing gut plain suture and this information was missing on the packet.

• Brand Name: SURGICAL GUT SUTURE -PLAIN
• Type of Device: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 015
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125, co; l salvacar; ciudad juarez 3260 4; MX 32604
• Manufacturer Contact: mary szaro ; route 22 west po box 151; somerville, NJ 08876 ; 9082183464
• MDR Report Key: 4816039
• MDR Text Key: 17736899
• Report Number: 2210968-2015-06694
• Device Sequence Number: 1
• Product Code: GAL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 1915G
• Device Lot Number: JCM668
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/29/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/25/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/05/2015
• 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