MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-09-14 for PRECISION MEDICAL INC. 198705 EP5 manufactured by Precision Medical, Inc..
[26371070]
This event occurred on (b)(6) 2014. Precision medical inc was notified on september 2nd, 2015. The product involved was confiscated by the fire marshall at the time of the event, and has not been examined by precision medical. The event occurred in the patient's home. The husband is on oxygen, using the precision medical oxygen conserver. At the time of the event, the husband was in the kitchen, an explosion occurred, injuring both the husband and wife.
Patient Sequence No: 1, Text Type: N, H10
[26371071]
Husband on oxygen, there was an explosion injuring both the husband and wife.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523148-2015-00002 |
| MDR Report Key | 5091427 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-09-14 |
| Date of Report | 2015-09-08 |
| Date of Event | 2014-08-04 |
| Report Date | 2015-09-08 |
| Date Reported to FDA | 2015-09-08 |
| Date Mfgr Received | 2015-09-02 |
| Device Manufacturer Date | 2012-11-01 |
| Date Added to Maude | 2015-09-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JIM PARKER |
| Manufacturer Street | 300 HELD DR. |
| Manufacturer City | NORTHAMPTON PA 18067 |
| Manufacturer Country | US |
| Manufacturer Postal | 18067 |
| Manufacturer Phone | 6102626090 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PRECISION MEDICAL INC. |
| Generic Name | OXYGEN CONSERVER |
| Product Code | NFB |
| Date Received | 2015-09-14 |
| Model Number | 198705 |
| Catalog Number | EP5 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRECISION MEDICAL, INC. |
| Manufacturer Address | 300 HELD DR. NORTHAMPTON PA 18067 US 18067 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-09-14 |