MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature,study report with the FDA on 2017-12-19 for PDS PLATE UNKNOWN PRODUCT manufactured by Ethicon Inc..
[95236980]
Product complaint # (b)(4). To date, the device has not been returned. If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form. Citation: annals of otology, rhinology & laryngology 2017, vol. 126(10) 688? 692. Https://doi. Org/10. 1177/0003489417727.
Patient Sequence No: 1, Text Type: N, H10
[95236981]
It was reported in a journal article (title: postoperative nasal septal abscess following use of 2-octylcyanoacrylate and polydioxanone plate in open septorhinoplasty) that a patient underwent a primary open septorhinoplasty with placement of an autologous caudal septal extension graft on an unknown date and an absorbable implant was used. A small strip of absorbable plate was affixed with topical skin adhesive to the cephalic portion of the graft, which was subsequently sewn in place with suture. Following an uncomplicated course, patient presented on postoperative week 5 with a left-sided septal abscess extending to the nasal tip and columella. Incision and drainage was performed with culture (proteus mirabilis) directed antibiotics. Despite aggressive medical management to include daily wound irrigation and packing, the patient was returned to the operating room 2 weeks from initial abscess presentation, and the absorbable implant was removed. Cultures obtained at time of removal were positive for proteus mirabilis despite 2 weeks of aggressive wound care and sensitivity-specific antibiotic therapy. Following removal of the implant, the patient? S infection resolved over the following week; however, the patient sustained significant columella contraction and loss of tip support. Additional information will be requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2017-71859 |
| MDR Report Key | 7129499 |
| Report Source | LITERATURE,STUDY |
| Date Received | 2017-12-19 |
| Date of Report | 2017-11-28 |
| Date Mfgr Received | 2017-11-28 |
| Date Added to Maude | 2017-12-19 |
| 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 | DARLENE KYLE |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal | 088760151 |
| Manufacturer Phone | 9082182792 |
| Manufacturer G1 | ETHICON INC.- GMBH |
| Manufacturer Street | ROBERT-KOCH STRASSE 1 |
| Manufacturer City | NORDERSTEDT |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PDS PLATE UNKNOWN PRODUCT |
| Generic Name | POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE |
| Product Code | NHB |
| Date Received | 2017-12-19 |
| Catalog Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON INC. |
| Manufacturer Address | P.O. BOX 151, ROUTE 22 WEST SOMERVILLE 088760151 US 088760151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-12-19 |