MAUDE Adverse Event Report: COVIDIEN 90098843 MATERNITY PAD

Model Number 2022A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

An investigation is currently under way.Upon completion the results will be forwarded.

Event Description

It was reported to covidien on 4/18/2016 that the customer had an issue with a maternity pad.The customer states that the adhesive of the pad was unusually strong.Her leg was exposed to the adhesive which lead to her being hospitalized and treated with iv antibiotics for a skin infection.

Manufacturer Narrative

One returned sample was received from the customer.The sample was sent to the supplier for investigation.Testing was performed on the pad for microbiological and for adhesion.All tests passed and were within specification.A review of the device history record was not performed during this investigation as the lot number was not received with the complaint.All device history records are reviewed and approved by quality prior to release of product.Because there was no lot number, a date of manufacture could not be determined.This complaint will be considered unconfirmed.A root cause could not be identified.A possible root cause could be sensitivity to the adhesive directly on the skin or the fragile area the adhesive from the pad had shifted to.As this complaint will be unconfirmed, no corrective action is planned at this time.If additional information is received, the investigation will resume as needed.This complaint will be used for trending purposes.

• Brand Name: 90098843 MATERNITY PAD
• Type of Device: MATERNITY PAD
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5599759
• MDR Text Key: 43474070
• Report Number: 1282497-2016-00134
• Device Sequence Number: 1
• Product Code: HIL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 2022A
• Device Catalogue Number: 2022A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other