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 2018-02-26 for COLLATAPE 0100 manufactured by Integra Neurosciences Pr.
[100925484]
The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported information. Linked to mfg. Report number 1121308-2018-00013.
Patient Sequence No: 1, Text Type: N, H10
[100925485]
This is 1 of 2 reported complaints. It was reported by a doctor that a 0100 collatape was used on a graft placement with membrane procedure. However, about fifteen days post procedure, it was noted through x-ray that there were punctual cases of serious inflammation, heavy gingival redness and some bone loss around the implants. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1121308-2018-00012 |
| MDR Report Key | 7296198 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-02-26 |
| Date of Report | 2018-01-29 |
| Date Mfgr Received | 2018-03-08 |
| Date Added to Maude | 2018-02-26 |
| 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 |
| Reporter Occupation | DENTAL HYGIENIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER VIVIAN NELSON |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA NEUROSCIENCES PR |
| Manufacturer Street | ROAD 402 NORTH, KM 1.2 |
| Manufacturer City | ANASCO PR 00610 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00610 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COLLATAPE |
| Generic Name | DENTAL PRODUCTS |
| Product Code | LPG |
| Date Received | 2018-02-26 |
| Catalog Number | 0100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA NEUROSCIENCES PR |
| Manufacturer Address | ROAD 402 NORTH, KM 1.2 ROAD 402 NORTH, KM 1.2 ANASCO PR 00610 US 00610 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-02-26 |