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 2018-10-04 for BELKYRA SKIN GRID manufactured by Allergan (irvine).
[122785952]
(b)(4). 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, infection, red, hot, painful and lumps 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
[122785953]
Healthcare professional reported injecting a patient with belkyra. It is assumed the skin grid was used. Patient developed swelling after the injection for about 5 days which resolved. About 3 weeks later, the patient developed what was likely an infection that was red, hot, painful and swollen. The severity of the event was considered to be moderate. Patient was treated with augmentin and symptoms resolved 5 days later but still has a lump in their neck.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024601-2018-00014 |
| MDR Report Key | 7936061 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-10-04 |
| Date of Report | 2018-10-04 |
| Date of Event | 2018-03-01 |
| Date Mfgr Received | 2018-09-06 |
| Date Added to Maude | 2018-10-04 |
| 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 | IMPLANT, DERMAL, FOR AESTHETIC USE |
| Product Code | FZZ |
| Date Received | 2018-10-04 |
| Catalog Number | BELKYRA SKIN GRID |
| 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 (IRVINE) |
| Manufacturer Address | 2525 DUPONT DRIVE IRVINE CA 92612 US 92612 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-04 |