MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional, report with the FDA on 2019-04-07 for UPPER MODULE, COM1 BRZ-CG1-CUD-110 201665 manufactured by Allergan (dublin).
[141162682]
The reported hernia was assessed as a serious injury related to the use of the coolsculpting device. Coolsculpting treatments, as stated in the cs user manual, may cause new hernia formation or exacerbate pre-existing hernia, which may require surgical repair. Investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
[141162683]
A physician who is a coolsculpting provider and received coolsculpting treatment, developed a hernia following treatment. The physician reported that coolsculpting caused the hernia. She was treated on (b)(6) 2018 with one cycle of coolcore to the right upper abdomen. This is the exact location of the umbilical hernia. The patient began feeling pain when sleeping on the right side sometime in (b)(6) 2018. She went to the hospital in (b)(6) 2019 when the pain became constant. At that time, she was 27 weeks pregnant, so surgery could not be performed. She will have surgery after delivery and is now on partial bedrest. No pre-existing hernia was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007215625-2019-00001 |
| MDR Report Key | 8489924 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2019-04-07 |
| Date of Report | 2019-04-07 |
| Date of Event | 2018-11-15 |
| Date Mfgr Received | 2019-03-08 |
| Date Added to Maude | 2019-04-07 |
| 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 | MS. JENNIFER CLETO |
| Manufacturer Street | 4410 ROSEWOOD DR. |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal | 94588 |
| Manufacturer Phone | 9256214130 |
| Manufacturer G1 | ALLERGAN (PLEASANTON) |
| Manufacturer Street | 4410 ROSEWOOD DR. |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94588 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UPPER MODULE, COM1 |
| Generic Name | DERMAL COOLING PACK/VACUUM/MASSAGER |
| Product Code | OOK |
| Date Received | 2019-04-07 |
| Model Number | BRZ-CG1-CUD-110 |
| Catalog Number | 201665 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLERGAN (DUBLIN) |
| Manufacturer Address | 4410 ROSEWOOD DR PLEASANTON, |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Congenital Not Applicablenomaly; 2. Required No Informationntervention | 2019-04-07 |