MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2015-12-07 for JUVEDERM (VOLUME/CONCENTRATION/ADDITIVE UNKNOWN) UNK JUVEDERM-CONC/ADD manufactured by Allergan (pringy).
[32858932]
Medwatch sent to fda on 12/07/2015. 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 granuloma formation, hard lumps and inflammatory response are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events. Device labeling addresses the reported events as follows: warnings: "treatment site reactions consist mainly of short-term inflammatory symptoms and generally resolve within 2 to 4 weeks. " precautions: "patients may experience late onset nodules with use of dermal fillers, including juv? Derm voluma? Xc. " adverse events: per table 1: treatment site responses by maximum severity occurring in > 5% of subjects after initial treatment (n = 265) possible treatment site responses post injection with juv? Derm voluma? Xc include tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching. ? Treatment site responses reported by = 5% of subjects included ache, acne, bulge, bumps, cheek larger upon waking up, dry patch, fine wrinkles, injection/needle marks, numbness, pigmentation from treatment, puffiness, rash, scratch near injection point, soreness, tightness, and yellowness.? Device and injection related adverse events occurring in = 1% of subjects included injection site hypertrophy (0. 7%), nodule (0. 7%), inflammation (0. 4%), injection site anesthesia (0. 4%), injection site dryness (0. 4%), injection site erosion (0. 4%), mass (0. 4%), contusion (0. 4%) and syncope (0. 4%). Post-market surveillance:? Juv? Derm voluma? Without lidocaine has been marketed outside the us since 2005, and juv? Derm voluma? With lidocaine has been marketed outside the us since 2009. As of december 31, 2012, the following aes were received from post-market surveillance for juv? Derm voluma? With and without lidocaine with a frequency = 5 and were not observed in the clinical study; this includes reports received globally from all sources including scientific journals and voluntary reports. All aes obtained through post-market surveillance are listed in order of number of reports received: inflammatory reaction, lack of correction, infection, migration, granuloma, allergic reaction, abscess, necrosis, numbness, and vision abnormalities. Reported treatments include: antibiotics, steroids, hyaluronidase, anti-inflammatories, anti-histamines, aspiration, radio frequency therapy, laser treatment, ice, massage, warm compress, analgesics, anti-viral, ultrasound, excision, drainage, and surgery.?
Patient Sequence No: 1, Text Type: N, H10
[32858933]
Healthcare professional who is also the patient reported that after injection with juvederm, they experienced a granuloma formation, lumps and an inflammatory response, and referred to as a "hard lumpy area. " it is unspecified if treatment was provided.
Patient Sequence No: 1, Text Type: D, B5
[50777768]
Medwatch sent to fda on 07/19/2016. Additional information: describe event or problem.
Patient Sequence No: 1, Text Type: N, H10
[50777769]
Further follow-up with the healthcare professional revealed that symptoms have resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005113652-2015-00800 |
| MDR Report Key | 5272893 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2015-12-07 |
| Date of Report | 2015-11-16 |
| Date of Event | 2015-11-02 |
| Date Mfgr Received | 2016-06-29 |
| Date Added to Maude | 2015-12-07 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 (PRINGY) |
| Manufacturer Street | ROUTE DE PROMERY ZONE ARTISANALE DE PRE-MAIRY |
| Manufacturer City | PRINGY 74370 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 74370 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JUVEDERM (VOLUME/CONCENTRATION/ADDITIVE UNKNOWN) |
| Generic Name | IMPLANT, DERMAL, FOR AESTHETIC USE |
| Product Code | LMH |
| Date Received | 2015-12-07 |
| Catalog Number | UNK JUVEDERM-CONC/ADD |
| 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 (PRINGY) |
| Manufacturer Address | ROUTE DE PROMERY ZONE ARTISANALE DE PRE-MAIRY PRINGY 74370 FR 74370 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-07 |