MAUDE Adverse Event Report: THE HYGENIC CORPORATION LANSINOH THERAPEARL 3 IN 1 BREAST THERAPY; REUSABLE HOT/COLD PACK

Model Number TP-BILNB1

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

Patient Problems Burn(s) (1757); Scar Tissue (2060)

Event Date 04/03/2020

Event Type  Injury  

Manufacturer Narrative

The suspect device was not returned, and the user accepted a replacement breast pack.Skin redness, sensitivity and burns are known risks of using local thermotherapy; these risks were evaluated in the products dfmea.Performance health originally received complaint on (b)(6) 2020 and was deemed to be reported as an emdr.Personnel submitted the electronic medwatch form (b)(6) 2020.However, it was inadvertently submitted in the webtrader test environment and not production.The complaint investigation has been completed per procedures and no further action concluded from the complaint.The employee is no longer with the company and the oversight was discovered during the exit transition; hence the late submission of this emdr.

Event Description

On (b)(6) 2020 the hygenic corporation was notified of an incident involving the therapearl lansinoh 3 - 1 breast therapy bilingual reusable hot/cold breast pack.The female user reports warming the breast pack in the microwave for 10 seconds.She placed the warmed breast pack inside the cover and applied to her breast.She did not feel this was warm enough, so she removed the breast pack from the cover and applied it directly to her breast and underneath her bra.She describes feeling a "burning sensation like skin burn".The user noticed the breast pack had developed a couple of tiny holes.She did not seek medical attention, the burn was self-healing and resulted in scabs and a scar.The breast pack was disposed of by the user before reporting the event and therefore we could not perform an inspection or thermal evaluation.The manufacturing record was reviewed and all specifications were met.A review of past complaints was performed regarding defects in the therapearl breast pack with known lot of 11546/01.This is the first complaint for this lot/part.

• Brand Name: LANSINOH THERAPEARL 3 IN 1 BREAST THERAPY
• Type of Device: REUSABLE HOT/COLD PACK
• Manufacturer (Section D): THE HYGENIC CORPORATION; 1245 home avenue; akron, oh
• Manufacturer Contact: gina gambosi ; 1245 home avenue; akron, oh ; 6120934
• MDR Report Key: 10286825
• MDR Text Key: 207338553
• Report Number: 1519375-2020-00005
• Device Sequence Number: 1
• Product Code: IME
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TP-BILNB1
• Device Lot Number: 11546/01
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Disability