MAUDE Adverse Event Report: COOK, INC. WORD CATHETER SILICONE BARTHOLIN GLAND BALLOON; KNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC

Catalog Number J-BGC-015055

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Allergic reaction (1701)

Event Date 04/17/2015

Event Type  Injury  

Event Description

The physician states the product caused an allergic reaction when placed in a female patient.According to the initial reporter, the patient did not require any additional procedures due to this occurrence.Additional information has been requested, but it was not available at the time of this report.

Manufacturer Narrative

(b)(4).Unknown as not provided by the reporter.The event is currently under investigation.

Manufacturer Narrative

During investigation the device complaint history was reviewed.Biocompatibility test reports performed on the device materials included cytotoxicity, intracutaneous reactivity, sensitization, subchronic toxicity, 2 week muscle implant, and acute systemic toxicity.No product was returned for evaluation.The complaint is confirmed based on customer testimony.There is no evidence to suggest that the device was not manufactured to specification.Without any further information on the patient history, condition or the medical procedure performed the root cause of the incident was unable to be determined.No risk mitigation activities were deemed necessary at this time.The appropriate internal personnel have been notified.Similar complaints of this type of an occurrence will continue to be monitored.

Event Description

Product caused allergic reaction.A section of the device d/d not remain inside the pt's body.The patient d/d not require any add'l procedures due to this occurrence.According to the initial reporter, the patient d/d experience and adverse effect due to this occurrence allergic reaction.

• Brand Name: WORD CATHETER SILICONE BARTHOLIN GLAND BALLOON
• Type of Device: KNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: larry pool, mgr ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4781840
• MDR Text Key: 5855201
• Report Number: 1820334-2015-00291
• Device Sequence Number: 1
• Product Code: KNA
• Combination Product (y/n): N
• PMA/PMN Number: K102141
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: J-BGC-015055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/17/2015
• Event Location: Hospital
• Date Manufacturer Received: 04/17/2015
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening