MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-23 for THERAPEARL BREAST PACK TP-LANSINOH manufactured by Hygenic Corporation.
[106256030]
Initial report was received 3/16/18. On 3/19/18 the hygenic team decided based on the initial information received that it was not a reportable event. We then received further information on 3/29/18. The team met again to review the additional information and determined it now qualifies as a reportable event. The product is intended to be heated, however the patient heated the product inside the cloth cover causing the button on the cover to become hot. The patient does not have full feeling in her breast and did not detect the burning sensation right away. The product was returned and inspected and was found to meet product specification.
Patient Sequence No: 1, Text Type: N, H10
[106256071]
We have received varying accounts of the incident from the patient's husband with respect to the heating and use of the therapearl breast pack. Initially, the husband stated that he microwaved the pack for "less than one minute". In a subsequent communication, the husband stated that it was his wife who microwaved the pack, and that she did so for the time recommended on the package. The husband also advised that his wife "may have microwaved it in the [cloth] sleeve. " the husband reported that he was able to safely handle the pack and carry it from the microwave to the chair where his wife was sitting. His wife then allegedly placed the breast pack inside her shirt on her breast on the side where she was experiencing a clogged duct. Shortly after placing the pack on her breast, the patient realized it was burning her and quickly removed the pack. The husband stated his wife believed it was the plastic button on the cloth sleeve that covers the pack that was the hot component which burnt her outer breast. The patient has previously had breast enlargement surgery and did not have full feeling in all of her breast at the time of the incident due to tight and thin skin and scar tissue, which is why she did not realize the temperature of the pack and that it was affecting her skin. The patient went to her primary care doctor regarding the burn. Per the husband, the primary care doctor stated that it was a significant burn and referred the patient to a dermatologist for further intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1519375-2018-00002 |
| MDR Report Key | 7451510 |
| Date Received | 2018-04-23 |
| Date of Report | 2018-04-05 |
| Date of Event | 2018-02-23 |
| Date Mfgr Received | 2018-03-16 |
| Date Added to Maude | 2018-04-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | HEATHER HAILER |
| Manufacturer Street | 1245 HOME AVE |
| Manufacturer City | AKRON OH 44310 |
| Manufacturer Country | US |
| Manufacturer Postal | 44310 |
| Manufacturer Phone | 3306338460 |
| Manufacturer G1 | SHANGHI CHUANGSHI LTD |
| Manufacturer Street | 388, ZHANGLIANTANG ROAD LIANTANG TOWN,QINGPU DISTRICT |
| Manufacturer City | SHANGHAI, P. R., CHINA |
| Manufacturer Country | CH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | THERAPEARL BREAST PACK |
| Generic Name | HOT/COLD GEL COMPRESS |
| Product Code | IME |
| Date Received | 2018-04-23 |
| Returned To Mfg | 2018-03-23 |
| Catalog Number | TP-LANSINOH |
| Lot Number | 02537-01 |
| Operator | PATIENT FAMILY MEMBER OR FRIEND |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HYGENIC CORPORATION |
| Manufacturer Address | 1245 HOME AVE AKRON OH 44310 US 44310 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-04-23 |