MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-11-19 for SEAL RITE MASK WITH ONE WAY VALVE 120 manufactured by Enter Medical Corp.
[5107502]
The issues with the suspect medical device, seal rite masks, were initially reported to the importer of this device, the (b)(4), on (b)(6) 2014 by a customer who purchased and used this mask in a (b)(4) training course. Below are the initial reporter's own words: "i purchased the seal rite masks to replace my existing seal easy masks. I used them this past weekend in lifeguard training and was very disappointed. Immediately the masks began to come apart, would not stay inflated, the valve to adjust air came apart on many masks, water seeped into the mask and some just leaked air constantly. " (b)(4) immediately stopped selling these masks and informed their contract mfr ((b)(4) of the issues on 05/24/2014. (b)(4) did their best to recall the defective medical devices sold. (b)(4) and (b)(4) worked closely to rectify these defects. Since early june, 2014, all the defects have been rectified. Please reference mw5036511 and mfr# 3006157842-2014-00001.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003197958-2014-00001 |
| MDR Report Key | 4262480 |
| Date Received | 2014-11-19 |
| Date of Report | 2014-05-24 |
| Date of Event | 2014-05-23 |
| Date Facility Aware | 2014-05-23 |
| Report Date | 2014-05-24 |
| Date Added to Maude | 2014-11-19 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 Street | 2012 W. COLLEGE AVE. |
| Manufacturer City | NORMAL IL 617610000 |
| Manufacturer Country | US |
| Manufacturer Postal | 617610000 |
| Manufacturer G1 | THE LIFEGUARD STORE INC. |
| Manufacturer Street | 2012 W. COLLEGE AVE. |
| Manufacturer City | NORMAL IL 61761000 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 61761 0000 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SEAL RITE MASK WITH ONE WAY VALVE |
| Product Code | BSJ |
| Date Received | 2014-11-19 |
| Model Number | 120 |
| Lot Number | 14015 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENTER MEDICAL CORP |
| Manufacturer Address | CHIA YI COUNTY TW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-19 |