MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05,06,07 report with the FDA on 2015-05-06 for PFR95 PART FILT RESP 46727 991046727 manufactured by Halyard Health.
[20070738]
A report was received from (b)(6) stating the doctor had a reaction to the face masks. The doctor experienced sore throat, runny nose, nasal blockage, laryngitis and skin reaction around the mouth and nose. The doctor diagnosed and self treated herself with anti-histamines and a cortisone based topical ointment. No additional information was provided in regards to the doctor's status.
Patient Sequence No: 1, Text Type: D, B5
[20249194]
(b)(4). A review of the device history record has been completed. The device history record for the lot number involved in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements. Root cause could not be determined. Six unused masks were returned but a lot number and the original packaging were not provided. All six devices were intact and had no rough surfaces, excess material or other visual defects. (b)(4) health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred. This product incident is documented in the halyard health complaint database and identified as complaint (b)(4). This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a halyard health product is defective or caused serious injury.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616096-2015-00004 |
| MDR Report Key | 4751326 |
| Report Source | 00,01,05,06,07 |
| Date Received | 2015-05-06 |
| Date of Report | 2015-04-10 |
| Date of Event | 2015-02-18 |
| Date Mfgr Received | 2015-04-10 |
| Device Manufacturer Date | 2014-10-19 |
| Date Added to Maude | 2015-05-06 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. LISA CLARK |
| Manufacturer Street | 5405 WINDWARD PARKWAY |
| Manufacturer City | ALPHARETTA GA 30004 |
| Manufacturer Country | US |
| Manufacturer Postal | 30004 |
| Manufacturer Phone | 4704485444 |
| Manufacturer G1 | LA ADA DE ACUNA |
| Manufacturer Street | KM 4.5 CARRETERRA PRESA LA AMISTAD |
| Manufacturer City | CIUDAD DE ACUNA 26200 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 26200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PFR95 PART FILT RESP |
| Generic Name | RESPIRATOR FACE MASK |
| Product Code | MSH |
| Date Received | 2015-05-06 |
| Returned To Mfg | 2015-04-13 |
| Model Number | 46727 |
| Catalog Number | 991046727 |
| Lot Number | AM4290831 |
| Device Expiration Date | 2019-09-01 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HALYARD HEALTH |
| Manufacturer Address | 5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-05-06 |