MAUDE Adverse Event Report: PURITAN MEDICAL PRODUCTS COMPANY LLC PUR-WRAP; ABSORBENT TIPPED APPLICATOR

Model Number 25-806 1 PD

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2014

Event Type  malfunction  

Event Description

Tip fell off swab during vaginal exam, samples are not available.

Manufacturer Narrative

Batch records and retention samples were examined.No anomalies were noted.The device was not returned for eval.Mechanical test on the retained samples from the suspect lots has been performed: all the tested swabs were normal.We are unable to determine a root cause for the reported event.Our investigation could not confirm any malfunction or defect in the device lots associated with this incident.This is the (b)(4) swabs manufactured each year.

• Brand Name: PUR-WRAP
• Type of Device: ABSORBENT TIPPED APPLICATOR
• Manufacturer (Section D): PURITAN MEDICAL PRODUCTS COMPANY LLC
• Manufacturer Contact: william young ; 31 school st.; p.o. box 149; guilford, ME 04443 ; 2078763311
• MDR Report Key: 4041730
• MDR Text Key: 4905382
• Report Number: 1216735-2014-00001
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/30/2014

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: Health Professional
• Device Model Number: 25-806 1 PD
• Device Catalogue Number: 25-806 1 PD
• Device Lot Number: 3425 OR 3503
• Other Device ID Number: 04/01/2018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2013
• 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 Age: 30 YR
• Patient Weight: 59