MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-07-24 for 3M ESPE RETRACTION CAPSULE 56942 manufactured by 3m Deutschland Gmbh.
[4752535]
A dental office returned two capsules of 3m (b)(4) retraction capsule in which the tips had broken off during use in the patient's mouth. No adverse health effects have occurred as a result of these events and this report is being made because of the potential for aspiration of the small part. The capsules were stored outside of their protective packaging, which contributed to the noted breakage.
Patient Sequence No: 1, Text Type: D, B5
[12272294]
The entire box of capsules returned to 3m (b)(4) were found to be removed from their protective foil wrappers. There were two returned that the doctor had attempted to use, but the tip separated from the capsule body. The removal from the protective foil wrappers is a handling error, because the capsules storage is described in the instructions for use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611385-2014-00007 |
| MDR Report Key | 3988104 |
| Report Source | 05 |
| Date Received | 2014-07-24 |
| Date of Report | 2014-06-17 |
| Date Mfgr Received | 2014-06-17 |
| Date Added to Maude | 2014-08-19 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | CARL-SCHURZ-STRABE 1 |
| Manufacturer City | NEUSS 41453 |
| Manufacturer Country | GM |
| Manufacturer Postal | 41453 |
| Manufacturer Phone | 9815270013 |
| Manufacturer G1 | ESPE PLATZ |
| Manufacturer Street | ESPE PLATZ |
| Manufacturer City | SEEFELD D82229 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D82229 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M ESPE RETRACTION CAPSULE |
| Generic Name | RETRACTION CAPSULE |
| Product Code | MVL |
| Date Received | 2014-07-24 |
| Returned To Mfg | 2014-06-24 |
| Catalog Number | 56942 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M DEUTSCHLAND GMBH |
| Manufacturer Address | NEUSS GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-24 |