MAUDE Adverse Event Report: ETHICON INC. ENDO SUTURE UNKNOWN PRODUCT; LAPROSCOPE, GENERAL & PLASTIC SURGERY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Sepsis (2067); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is related to data research, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.The single complaint was reported with multiple events.There are no additional details regarding the additional events.If further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported via clinical evaluation report from a related research activity database (drra) that patients underwent an unknown procedure on unknown date and suture was used.The reported complication experienced by the following with corresponding intervention: 16 patients had bleeding peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization.1 patient had wound disruption peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization.2 patients had surgical site infection peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization.4 patients had sepsis peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization.No additional information was provided.

• Brand Name: ENDO SUTURE UNKNOWN PRODUCT
• Type of Device: LAPROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9572205
• MDR Text Key: 189353620
• Report Number: 2210968-2020-00230
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/14/2019
• Initial Date FDA Received: 01/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention