MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-10-13 for BELKYRA SKIN GRID manufactured by Allergan (irvine).
[89359547]
Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. The events of swelling, redness, pain, malaise, unable to sleep and (b)(6) infection are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events. Device labeling for belkyra? : warnings and precautions. For topical use only. Do not inject through the transferred grid markings. Do no use on broken or damaged skin.
Patient Sequence No: 1, Text Type: N, H10
[89359548]
Healthcare professional reported injecting a patient with belkyra using the skin grid to the submental fat region. Patient developed swelling after the injection and 18 days later had swelling beyond normal expectations with redness and pain. The patient had malaise and was unable to sleep after the injection. The swollen area was aspirated and the patient was commenced on cephalexin. Three days later, the patient had another aspiration and commenced on dicloxacillin. After the belkyra had been drained, the healthcare professional noticed lymphocytes in the area which indicated an infection. A culture of the aspiration showed heavy growth of (b)(6). Patient symptoms are improving.
Patient Sequence No: 1, Text Type: D, B5
[96491682]
The events necrotic tissue, abscess and dimpling/induration are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.
Patient Sequence No: 1, Text Type: N, H10
[96491683]
Additional information: injection area was prepped with chlorhexidine 0. 05% antiseptic resolution prior to injection. Patient was advised to use cold compress for short periods after the injection and to keep the area clean and hydrated. Patient was free from any infection/inflammation prior to injection. Patient had developed a delayed abscess within the necrotic tissue of the submental fat which required antibiotics therapy and aspiration of significant swelling. Patient has had multiple reviews since treatment was provided and ongoing support. Patient still has a small submental abscess and related dimpling/induration of the skin. Symptoms are ongoing and patient continues to take oral antibiotics. Patient may be left with permanent scarring in the area and an undesirable cosmetic outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024601-2017-00009 |
| MDR Report Key | 6949513 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-10-13 |
| Date of Report | 2017-11-06 |
| Date of Event | 2017-09-01 |
| Date Mfgr Received | 2017-11-02 |
| Date Added to Maude | 2017-10-13 |
| 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. SUZANNE WOJCIK |
| Manufacturer Street | 301 W HOWARD LANE SUITE 100 |
| Manufacturer City | AUSTIN TX 78753 |
| Manufacturer Country | US |
| Manufacturer Postal | 78753 |
| Manufacturer Phone | 7372473605 |
| Manufacturer G1 | ALLERGAN (IRVINE) |
| Manufacturer Street | 2525 DUPONT DRIVE |
| Manufacturer City | IRVINE CA 92612 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92612 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BELKYRA SKIN GRID |
| Generic Name | MARKER, SKIN |
| Product Code | FZZ |
| Date Received | 2017-10-13 |
| Catalog Number | BELKYRA SKIN GRID |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLERGAN (IRVINE) |
| Manufacturer Address | 2525 DUPONT DRIVE IRVINE CA 92612 US 92612 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention; 2. Deathisabilit | 2017-10-13 |