MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS WEDGIE - 3"X4"X5"

Model Number 91014

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Type  malfunction  

Event Description

The customer reported mold on the wedgie product.No pt incident/injury was reported.

Manufacturer Narrative

(b)(4).The customer reported mold on the wedgie product.No pt incident/injury was reported.This complaint is being reported, as no material is available for eval to confirm that there is no mold in/on the product.There is no current evidence that mold will grow inside the wedgie product (gel matrix).There is no evidence of gel "sweating" through the bladder for mold to grow on the outside of the bladder.The bladder is made of vinyl, which is a different material from that used for the gel-e donut product.No product malfunction can be confirmed/determined, as no material is available for eval/testing.

• Brand Name: WEDGIE - 3"X4"X5"
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd.; andover MA 01810
• Manufacturer Contact: nancy ataide ; 3000 minuteman rd.; andover, MA 01810 ; 9786597429
• MDR Report Key: 4309731
• MDR Text Key: 5192659
• Report Number: 1218950-2014-07330
• Device Sequence Number: 1
• Product Code: FMP
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 91014
• Device Lot Number: LOT CODE NOT PROVIDED - NO
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1