MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-11-30 for PREVENTION PLUS CHEMO ISOLATION GOWN NON27457M manufactured by Medline Industries, Inc..
[2510532]
A clinician developed a severe allergic reaction after putting on the gown.
Patient Sequence No: 1, Text Type: D, B5
[9491935]
When the clinician put on the gown, she immediately experienced a rash around her mouth and on her face. She also had difficulty breathing. She is a known asthmatic with multiple allergies. She used her inhaler, was seen by the occupational health practitioner and then given an antihistamine with good results. The sample was not returned for evaluation. We have not received any other similar complaints for this product. No corrective action is indicated at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2011-00060 |
| MDR Report Key | 2362240 |
| Report Source | 05 |
| Date Received | 2011-11-30 |
| Date of Report | 2011-11-30 |
| Date of Event | 2011-10-27 |
| Date Mfgr Received | 2011-11-02 |
| Date Added to Maude | 2012-07-19 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JULIE FINLEY |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476434709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PREVENTION PLUS CHEMO ISOLATION GOWN |
| Generic Name | ISOLATION GOWN |
| Product Code | FME |
| Date Received | 2011-11-30 |
| Model Number | NON27457M |
| Lot Number | 1051824992 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | MUNDELEIN IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-11-30 |