MAUDE Adverse Event Report: ALLCARE, INC LAP SPONGES 18 X 18

Catalog Number AL1818

Device Problems Delivered as Unsterile Product (1421); Out-Of-Box Failure (2311); Contamination of Device Ingredient or Reagent (2901); Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 08/02/2014

Event Type  malfunction  

Event Description

One of the laps out of the sterile pack for the cesarean section was dirty with a black substance on it, like someone stepped on it.The entire 5-pack of those laps was removed from the table.Diagnosis or reason for use: lap sponges for use during cesarean delivery procedure.

• Brand Name: LAP SPONGES 18 X 18
• Type of Device: LAP SPONGES 18 X 18
• Manufacturer (Section D): ALLCARE, INC
• MDR Report Key: 3999602
• MDR Text Key: 15322716
• Report Number: MW5037672
• Device Sequence Number: 1
• Product Code: GDY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: AL1818
• Device Lot Number: 21NE02
• Other Device ID Number: REF# AL1818
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1