MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD DAVOL SILICONE ROUND SINGLE DRAIN

Catalog Number 0070310

Device Problem Torn Material (3024)

Patient Problem No Information (3190)

Event Date 03/14/2014

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2014 the drain was placed for a hip operation.On (b)(6) 2014 when the drain was removed slowly from the patient, the distal end of the tube (approximately 32mm) was found to be torn off.The tube segment was removed from the patient's body via a surgical operation.

Manufacturer Narrative

Investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

• Brand Name: DAVOL SILICONE ROUND SINGLE DRAIN
• 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: beverly schaner ; 8195 industrial blvd.; covington, GA 30014 ; 7707846100
• MDR Report Key: 3779141
• MDR Text Key: 4438245
• Report Number: 1018233-2014-00083
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0070310
• Device Lot Number: NGXH6757
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/03/2014
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 03/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 11 YR