MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-07-26 for PREFGEL 0.6ML, 5-PACK 075.203W manufactured by Institut Straumann Ag.
[115124456]
Review of the complaint database determined that no other complaints were registered reporting similar mix-up issues. The complaint is input to the post market surveillance process at straumann which tracks and trends complaints which is evaluated within the regular pms report. If trends are identified during this process, then this will be an input to capa to define any necessary additional actions.
Patient Sequence No: 1, Text Type: N, H10
[115124457]
The clinician planned a periodontal surgery to treat an intraosseous / furcation defect in site #16 in a (b)(6) male patient on the treatment plan is to apply prefgel (edta) to the root surface and leave it for two minutes to condition the surface. The intended use of prefgel is for topical application onto exposed root surfaces during periodontal surgery in order to remove the smear layer. After rinsing the prefgel from the surgical area, straumann emdogain is applied. The intended use of emdogain is for topical application in conjunction with periodontal surgery to provide for regeneration of tooth support lost to periodontal disease or trauma. The emdogain remains in situ. During the planned surgery on (b)(6) the clinician confused prefgel with emdogain. This means that the clinician applied the 075. 203w prefgel 0. 6 ml lot mp183 into the non-bleeding augmentation site and left it in the defect in the patient for 72 hours. The clinician recalled the patient for a follow-up treatment on (b)(6) to clean and wash the wound.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222315-2018-00416 |
| MDR Report Key | 7722865 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-07-26 |
| Date of Report | 2018-07-26 |
| Date of Event | 2018-06-26 |
| Date Mfgr Received | 2018-06-29 |
| Device Manufacturer Date | 2017-02-28 |
| Date Added to Maude | 2018-07-26 |
| 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 | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. JENNIFER JACKSON |
| Manufacturer Street | 60 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9787472509 |
| Manufacturer G1 | INSTITUT STRAUMANN AG |
| Manufacturer Street | PETER MERIAN-WEG 12 |
| Manufacturer City | BASEL, CH-4002 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH-4002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PREFGEL 0.6ML, 5-PACK |
| Generic Name | ROOT SURFACE CONDITIONER |
| Product Code | KJJ |
| Date Received | 2018-07-26 |
| Model Number | NA |
| Catalog Number | 075.203W |
| Lot Number | MP183 |
| Device Expiration Date | 2019-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INSTITUT STRAUMANN AG |
| Manufacturer Address | PETER MERIAN-WEG 12 BASEL, CH-4002 SZ CH-4002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-07-26 |