MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD UNKNOWN

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

Patient Problem Laceration(s) (1946)

Event Date 02/18/2014

Event Type  Injury  

Event Description

It was reported that the foley catheter was placed in the patient for urinary retention.The physician had difficulty visualizing the urethra upon insertion due to patient movement.The physician was unsuccessful in placing the catheter in the urethra.The catheter slid into the vaginal introitus.The catheter was withdrawn and a small amount of blood was noted on the tip of the catheter.After a few minutes, a moderate amount of blood was noted on the pad under the patient.The physician noted a laceration to the vulva approximately 0.5 cm in size.The physician applied direct pressure to the laceration and the bleeding immediately stopped.The catheter was the placed used lidocain jelly with an immediate return of 1400 ml of clear yellow urine.

Manufacturer Narrative

The sample was not returned.The lot number is unknown; therefore, the device history record could not be reviewed.The reported issue appears to be most likely an unfortunate adverse event that occurred during the placement of the catheter which is not related to the device.However; the sample was not rec'd for evaluation and therefore it was determined the complaint is inconclusive.(b)(4).

• Brand Name: UNKNOWN
• Type of Device: UNK
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD; nogales, sonora ; MX
• Manufacturer (Section G): PRODUCTOS PARA EL CUIDADO DE LA SALUD; km. 7 carretera internacional; nogales, sonora 8562 1; MX 85621
• Manufacturer Contact: christy lewis ; 8195 industrial blvd.; covington, GA 30014 ; 7707846100
• MDR Report Key: 3839085
• MDR Text Key: 4680126
• Report Number: 1018233-2014-00105
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/28/2014

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2014
• Initial Date FDA Received: 05/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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