MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,other report with the FDA on 2017-11-08 for SCRUB PANTS/LARGE 991069702 69702 manufactured by Halyard Health.
[91383341]
A review of the device history record is in-progress. The actual complaint product was not returned for evaluation. Root cause could not be determined. All information reasonably known as of 8-nov-17 has been included in this health authority report. Should additional information be obtained, a follow-up health authority report will be provided. The information provided by halyard health represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health. Halyard 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).
Patient Sequence No: 1, Text Type: N, H10
[91383342]
It was reported that the patient underwent an mri scan while wearing disposable scrub pants. It was alleged that the patient sustained skin burns on the hips and legs during the mri. Per additional information received 8 nov 2017, the mri scan was of the cervical spine. The patient's skin and the material of the scrub pants became scorched. The patient was burned on the inner side of the right breast. No further information has been provided to halyard at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011270181-2017-00009 |
| MDR Report Key | 7011158 |
| Report Source | DISTRIBUTOR,FOREIGN,OTHER |
| Date Received | 2017-11-08 |
| Date of Report | 2017-12-07 |
| Date of Event | 2017-09-13 |
| Date Mfgr Received | 2017-12-07 |
| Device Manufacturer Date | 2015-03-11 |
| Date Added to Maude | 2017-11-08 |
| 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 | 3 |
| Event Location | 3 |
| 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 | LIANYUNGANG AIYEH NON-WOVEN PRODUCTS CO., LTD. |
| Manufacturer Street | NO. 9 YUNYANG RD. HUANGJIUNIAN EXPORT PROCESSING ZONE |
| Manufacturer City | LIANYUNGANG, JIANGSU |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCRUB PANTS/LARGE |
| Generic Name | SCRUB PANTS |
| Product Code | LYU |
| Date Received | 2017-11-08 |
| Model Number | 991069702 |
| Catalog Number | 69702 |
| Lot Number | CA5067006 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Other | 2017-11-08 |