MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-04-30 for UPPER MODULE, COM1 201665 manufactured by Allergan (pleasanton).
[143606828]
The reported recurrence of hernia and subsequent surgical repair was assessed as a serious injury related to the use of the coolsculpting device. Hernia generally requires surgical intervention to correct and prevent further complications. The occurrence of hernia is a risk inherent to the coolsculpting procedure and is detailed in the coolsculpting user manual under warnings, where it states, "the effect of performing a coolsculpting 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 is unable to obtain device and treatment information because the patient had refused to provide consent for allergan to contact her coolsculpting treatment provider. No further investigation can be performed.
Patient Sequence No: 1, Text Type: N, H10
[143606829]
On april 3, 2019. Allergan received report from a patient that she underwent surgical repair of a pre-existing hernia approximately 6 months after she received coolsculpting treatment on the upper abdomen. The patient confirmed that prior to receiving coolsculpting treatment between (b)(6) and (b)(6) 2018, she already had a pre-existing supraumbilical hernia for which she had undergone surgical repair. The patient stated that due to her petite frame the 2 coolsculpting applicators placed vertically and parallel to each other had also covered the surgical site. Between november and (b)(6) 2018, 6 months after her coolsculpting treatment, she experienced pain on the surgical site, found out the hernia had recurred and underwent a second surgical hernia repair. The patient refused to provide consent for allergan to contact her coolsculpting treatment provider and also declined to provide additional information on the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007215625-2019-00015 |
| MDR Report Key | 8566450 |
| Report Source | CONSUMER |
| Date Received | 2019-04-30 |
| Date of Report | 2019-04-30 |
| Date Mfgr Received | 2019-04-02 |
| Date Added to Maude | 2019-04-30 |
| 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 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 | 2019-04-30 |
| 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 | 2019-04-30 |