MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-03-07 for UPPER MODULE, COM1 201665 manufactured by Allergan (pleasanton).
[138209088]
The reported hernia requiring surgery 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. System logs have been retrieved and submitted for review. A supplemental mdr will be submitted once review is complete.
Patient Sequence No: 1, Text Type: N, H10
[138209089]
On (b)(6) 2019, allergan became aware that a patient who received coolsculpting treatment to his abdomen on (b)(6) 2018 using a cooladvantage plus applicator was diagnosed with supraumbilical hernia requiring surgery on (b)(6) 2019. Patient denies having pre-existing hernia and the practice stated it was difficult to assess for hernia prior to cs treatment because the patient was obese.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007215625-2019-00008 |
| MDR Report Key | 8402237 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-03-07 |
| Date of Report | 2019-04-15 |
| Date Mfgr Received | 2019-02-08 |
| Date Added to Maude | 2019-03-07 |
| 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 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 | 2019-03-07 |
| 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 | 2019-03-07 |