MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-04-24 for UPPER MODULE, COM1 201665 manufactured by Allergan (pleasanton).
[142945028]
This event was initially reported on (b)(6) 2019 in mfr report # 3007215625-2018-00012. The mfr report #, however, incorrectly stated 2018 instead of 2019. This report is now being submitted with the correct mfr reprt # 3007215625-2019-00014.
Patient Sequence No: 1, Text Type: N, H10
[142945029]
On (b)(6) 2019, allergan was made aware of an online post where the reporter stated she had received coolsculpting treatment and ended up needing hernia surgery on the treated area four months post treatment. Diligent efforts have been made to obtain additional information on the event, treatment provider, treatment details and device used, however no additional information has been received from the reporter to date. Even though the allegation remains unsubstantiated at this point, out of abundance of caution this case was assessed and addressed conservatively as a reportable event, even with the limited information available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007215625-2019-00014 |
| MDR Report Key | 8545360 |
| Report Source | CONSUMER |
| Date Received | 2019-04-24 |
| Date of Report | 2019-04-23 |
| Date Mfgr Received | 2019-04-12 |
| Date Added to Maude | 2019-04-24 |
| 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 | 2019-04-24 |
| 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. Deathisabilit | 2019-04-24 |