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

Catalog Number 635H

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

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Inflammation (1932); Surgical procedure (2357)

Event Date 05/04/2015

Event Type  Injury  

Event Description

It was reported that the patient underwent carpal tunnel surgical procedure on an unknown date and suture was used.Following the procedure, the patient experienced inflammation, infection or dehiscence.The patient was taken back to the or and underwent wash out of the wound.Additional information has been requested.

Manufacturer Narrative

The patient was brought back to the operating room to have the wound flushed out and debrided.The actual device batch number associated with this event is not known.The following are possible batch numbers: batch jbk178 mfg date: 02/19/2015, exp date: 07/31/2019, batch hl6268 mfg date: 10/15/2014, exp date: 07/31/2019.In addition, a review of the batch manufacturing records for the possible batch numbers was conducted and the batches met all finished goods release criteria.Representative samples were returned for evaluation.They were visually and functionally examined for strength and they met requirements.

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.

• Brand Name: SURGICAL GUT SUTURE - CHROMIC
• 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: 4810963
• MDR Text Key: 5923037
• Report Number: 2210968-2015-06549
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2015
• 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: 635H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2015
• 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