MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-04-04 for SCOTCHBOND UNIVERSAL ETCHANT 41263 manufactured by 3m Deutschland Gmbh.
[21755454]
(b)(6) patient experienced a burn in the eye after an incidental exposure to 3m (tm) espe (tm) scotchbond (tm) universal etchant. Dental office reported they tested the subject product before the procedure and it was working properly; however, the syringe tip came off and etchant spilled in patient's eye. The dental professionals immediately flushed the eye, and the patient was sent to the emergency room for further treatment. The patient received another eye flush at the er and was prescribed eye salve to be applied every 2 hours. The patient was seen at the hospital for follow-up the following day ((b)(6)) where it was recommended that salve be applied every hour and to return on (b)(6) for another evaluation. The mother of the patient reported that the diagnosis is a burn in the eye. The dental office has made several attempts to follow-up for current patient status; no response has been received at this time.
Patient Sequence No: 1, Text Type: D, B5
[21904268]
It remains unclear how the tip of the syringe came off allowing etchant to spill in the patient's eye; dental office is unwilling, at this time, to return the complaint sample for evaluation by 3m espe. The global clinical complaint history for the subject product is favorable. There have been no other complaints of this nature reported, including no reports of the etchant syringe tip coming off before or during use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611385-2013-00006 |
| MDR Report Key | 3049516 |
| Report Source | 05 |
| Date Received | 2013-04-04 |
| Date of Report | 2013-03-14 |
| Date of Event | 2013-03-13 |
| Date Mfgr Received | 2013-03-14 |
| Date Added to Maude | 2013-04-11 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DR. THOMAS MEINDL |
| Manufacturer Street | ESPE PLATZ |
| Manufacturer City | SEEFELD 82229 |
| Manufacturer Country | GM |
| Manufacturer Postal | 82229 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCOTCHBOND UNIVERSAL ETCHANT |
| Generic Name | ETCHING GEL |
| Product Code | EJK |
| Date Received | 2013-04-04 |
| Catalog Number | 41263 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M DEUTSCHLAND GMBH |
| Manufacturer Address | SEEFELD GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-04-04 |