MAUDE Adverse Event Report: KIMBERLY-CLARK HEALTH CARE ULTRA ZONED-IMPERVIOUS SURGICAL GOWN, X-LARGE, WITH TOWEL

Catalog Number 95321

Device Problem Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/25/2013

Event Type  malfunction  

Event Description

Kimberly-clark received a report stating, "one of our surgeons experienced strikethrough on a surgical gown.He was performing an exploratory laparotomy with sigmoid resection.It was a scheduled case.The strike through was on his arm which was covered with blood.He had to break scrub, wash his arm and then regown.This patient was positive for (b)(6)." kimberly-clark has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the kimberly-clark complaint database and identified as record (b)(4).

Manufacturer Narrative

We are unable to review the device history record as no lot number was provided for the device involved in this reported event.The device was not returned to kimberly-clark for evaluation, therefore we are unable to determine a root cause for the reported event.Information from this incident will be included in our product complaint and mdr trend reporting systems.Ongoing analysis of trend information is used to identify the need for additional investigations.Device not returned to kimberly-clark by customer.

• Brand Name: ULTRA ZONED-IMPERVIOUS SURGICAL GOWN, X-LARGE, WITH TOWEL
• Type of Device: SURGICAL GOWN
• Manufacturer (Section D): KIMBERLY-CLARK HEALTH CARE; 1400 holcomb bridge rd; bldg 200; roswell GA 30076
• Manufacturer (Section G): AVENT DE HONDURAS S.A. DE C.V; parque industrial villanueva; carretera tegucigalpa; villanueva cortes ; HO
• Manufacturer Contact: ra/qa ae coordinator ; 1400 holcomb bridge rd; bldg 200; roswell, GA 30076 ; 7705877200
• MDR Report Key: 3545923
• MDR Text Key: 19298099
• Report Number: 9680646-2013-00011
• Device Sequence Number: 1
• Product Code: FYA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/02/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 95321
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/02/2013
• Initial Date FDA Received: 01/01/2014
• 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?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1