MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2014-11-19 for SEAL RITE MASK WITH ONE WAY VALVE 120 manufactured by Enter Medical Corp.
[21446575]
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 (b)(4) 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. The (b)(4) did their best to recall the defective medical devices sold. The (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 (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[21687927]
The seal rite mask with one-way valve consists of a circular cushioned mask which can be easily inflated by hand and a one-way non-rebreathing valve. The intended use of the device is for the (b)(4) to provide ventilation to the pt. The design spec is provided by the (b)(4) and mfg by the contract mfr (b)(4). The first batch of the product was shipped in (b)(4) 2014 to the (b)(4), then sold to the customers. On (b)(4)2014, the (b)(4) received complaints from a customer. The (b)(4) passed this info to (b)(4) on 05/24/2014, stopped selling and recalled the defective masks immediately. After thorough analysis, the following three issues were discovered: the plastic connector piece on the bladder falls apart when impacted by a great force (jumping into water). The upper plastic piece in the inflation valve also comes off under great force. A red port cap on the oxygen attachment port of the one-way valve also comes off under great force. (b)(4) rectified the issues with following three fixes: put three points of pvc glue on the plastic connector to hold it in place so that it doesn't come off. Do high-frequency binding between upper and lower plastic pieces in the inflation valve so that they stay attached even under great force. Modify the mold of the port cap to decrease the circumference of the base circle and increase the thickness on the bottom so they do not slide off easily. Since 06/10/2014, all known issues have been rectified and new masks and valves have been shipped. The (b)(4) has done their best to recall the defective masks and replace them with new updated masks.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006157842-2014-00001 |
| MDR Report Key | 4262163 |
| Report Source | 00 |
| 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 Mfgr Received | 2014-05-24 |
| Device Manufacturer Date | 2014-04-01 |
| Date Added to Maude | 2014-11-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 Contact | JOHN LEE |
| Manufacturer Street | 16F1 NO.16 JIAN BA ROAD CHUNG HO DISTRICT, |
| Manufacturer City | NEW TAIPEI CITY 23511 |
| Manufacturer Country | TW |
| Manufacturer Postal | 23511 |
| Manufacturer Phone | 282265221 |
| Manufacturer G1 | ENTER MEDICAL CORP |
| Single Use | 3 |
| Remedial Action | MA |
| 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 | Y |
| 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 |