MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-03-05 for UPPER MODULE, COM1 201665 manufactured by Allergan (dublin).
[137872045]
Pending investigation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[137872046]
A treatment provider reported that a patient was treated to the upper and lower abdomen, and bilateral flanks, on (b)(6) 2018, (b)(6) 2018 and (b)(6) 2018. The patient experienced pain for three months post treatment for which steroids were given. On (b)(6) 2018, the patient presented with nodules under the treated areas. By the time the manufacturer was notified of the event, the pain had subsided. The nodules were described as hard tissue that felt like baseballs, did not emit heat, and did not hurt. Two biopsies were performed and showed fat necrosis. An ultrasound showed tissue reaction to focus trauma and thickening of the tissue related to fat necrosis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007215625-2019-00021 |
| MDR Report Key | 8391899 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-03-05 |
| Date of Report | 2019-04-12 |
| Date of Event | 2018-09-07 |
| Date Mfgr Received | 2019-03-19 |
| Date Added to Maude | 2019-03-05 |
| 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 (DUBLIN) |
| Manufacturer Street | 5996 GLEASON DRIVE |
| Manufacturer City | DUBLIN CA |
| Manufacturer Country | US |
| 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 | 2019-03-05 |
| 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 (DUBLIN) |
| Manufacturer Address | 5996 GLEASON DRIVE DUBLIN CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-05 |