MAUDE Adverse Event Report: BAUSCH HEALTH AMERICAS, INC. (F/K/A VALEANT PHARMACEUTICALS PEDINOL EZ SWABS; APPLICATOR, ABSORBENT TIPPED, NON-STERILE

Lot Number POD1119

Device Problems Fluid/Blood Leak (1250); Defective Device (2588); Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Inadequate quantity of phenol provided in some containers.Some but not all swabs in container are reported to be inadequately saturated with phenol.It appears that phenol may be leaking from some of the packaging prior to activation.It appears that the black portion of the container may have backed out slightly allowing for the phenol to leak.

• Brand Name: PEDINOL EZ SWABS
• Type of Device: APPLICATOR, ABSORBENT TIPPED, NON-STERILE
• Manufacturer (Section D): BAUSCH HEALTH AMERICAS, INC. (F/K/A VALEANT PHARMACEUTICALS
• MDR Report Key: 10689424
• MDR Text Key: 211903683
• Report Number: MW5097253
• Device Sequence Number: 1
• Product Code: KXF
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial

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: No Information
• Device Lot Number: POD1119
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1