MAUDE Adverse Event Report: ETHICON INC. SUTURE UNKNOWN

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

Patient Problems Unspecified Infection (1930); Pus (2027); Other (for use when an appropriate patient code cannot be identified) (2200); Impaired Healing (2378)

Event Type  Injury  

Event Description

It was reported in a newspaper that a patient underwent caesarean surgery on an unknown date and unknown suture was used.Following the procedure, the patient experienced infection.The patient experienced delayed wound healing with wound that did not heal after approximately one year.The patient also experienced severe stomach ache.It was reported that the patient was not able to breastfeed due to infection.It was reported that after 35-40 days, pus occurred in between the stitches.Additional information has been 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.(b)(4).

Manufacturer Narrative

It was reported by the physician that the hospital has revamped the entire ot, changed all the surgical instruments, repainted, repaired ceiling and autoclave machine and have reported they are ¿not getting infections¿.

• Brand Name: SUTURE UNKNOWN
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 015
• Manufacturer (Section G): UNKNOWN; unknown; x
• Manufacturer Contact: mary szaro ; 9082183464
• MDR Report Key: 4863034
• MDR Text Key: 5812338
• Report Number: 2210968-2015-07396
• Device Sequence Number: 1
• Product Code: GAN
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/06/2015
• 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