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).
[89288480]
Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. The event of necrosis is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event. Device labeling for belkyra: warnings and precautions, for topical use only, do not inject through the transferred grid markings, do not use on broke or damaged skin.
Patient Sequence No: 1, Text Type: N, H10
[89288481]
Healthcare professional reported injecting a patient with belkyra? A little outside of the grid area. The patient developed skin necrosis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024601-2017-00008 |
| MDR Report Key | 6947380 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-10-13 |
| Date of Report | 2017-10-13 |
| Date of Event | 2017-09-11 |
| Date Mfgr Received | 2017-09-18 |
| 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 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 | 2017-10-13 |