MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-05-21 for UPPER MODULE, COM1 201665 manufactured by Allergan (pleasanton).
[145683422]
The reported occurrence of hernia was assessed as a serious injury related to the use of the cool-sculpting device. Although it could not be confirmed whether or not the patient will undergo a subsequent hernia repair, hernia generally requires surgical intervention to correct and prevent further complications. The occurrence of hernia is a risk inherent to the cool-sculpting procedure when a vacuum applicator is used, and this is detailed in the cool-sculpting user manual under warnings, where it states, "the effect of performing a cool-sculpting treatment with a vacuum applicator on a patient who has a hernia in or adjacent to the treatment site has not been studied. The applicator uses vacuum pressure to draw tissue into the applicator cup during the treatment. The vacuum pressure may therefore apply pressure on a pre-existing hernia or pre-existing structurally weak area such as a surgical scar, causing further complications. Physicians should examine that patient for evidence of pre-existing abdominal or femoral hernia prior to use of the device. " allergan has made diligent attempts to request additional information from the clinic, but no additional device and treatment information has been received to date. More information is being sought.
Patient Sequence No: 1, Text Type: N, H10
[145683423]
On 24-apr-2019, allergan received report from a treatment provider that a female patient received cool-sculpting treatment to the lower abdomen on (b)(6) 2017 using a coolmax applicator. Three months post treatment, the patient reported pain on the left side of the lower abdomen. The patient underwent ultrasound and was told she has a fat containing umbilical hernia.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007215625-2019-00018 |
| MDR Report Key | 8629201 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-05-21 |
| Date of Report | 2019-05-21 |
| Date of Event | 2017-10-15 |
| Date Mfgr Received | 2019-04-24 |
| Date Added to Maude | 2019-05-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 DRIVE |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal | 94588 |
| Manufacturer Phone | 9256214130 |
| Manufacturer G1 | ALLERGAN (PLEASANTON) |
| Manufacturer Street | 4410 ROSEWOOD DRIVE |
| 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 | 2019-05-21 |
| Catalog Number | 201665 |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLERGAN (PLEASANTON) |
| Manufacturer Address | 4410 ROSEWOOD DRIVE PLEASANTON CA 94588 US 94588 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-21 |