MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-08 for MEDICAL ACTION INDUSTRIES INC. ORT400 manufactured by Jiangsu Guangda Medical Material Group Co., Ltd..
[141307358]
Internal complaint opened under complaint number (b)(4). A trending analysis was performed; there are no trends related to this defect as pertains to the product. Site will continue to track and trend for this issue. The supplier has been notified of the issue.
Patient Sequence No: 1, Text Type: N, H10
[141307359]
Received customer complaint from distributor regarding event whereby or towel produced lint into surgical site during an unidentified procedure. Per distributor, after multiple good-faith attempts, the end-user remains unable or unwilling to provide additional information regarding the alleged event in order to contribute to further complaint investigation. There are no other details obtained as corresponds to the report. The complaint item is reference number (b)(4), or towel (non-xray detectable), medical action industries branded. The complaint lot was not reported or obtained from end-user.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030451-2019-00001 |
| MDR Report Key | 8493560 |
| Date Received | 2019-04-08 |
| Date of Report | 2019-04-05 |
| Date of Event | 2019-03-07 |
| Date Mfgr Received | 2019-03-07 |
| Date Added to Maude | 2019-04-08 |
| 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. NICHOLE EARLY |
| Manufacturer Street | 25 HEYWOOD ROAD |
| Manufacturer City | ARDEN NC 28704 |
| Manufacturer Country | US |
| Manufacturer Postal | 28704 |
| Manufacturer Phone | 8283387568 |
| Manufacturer G1 | MEDICAL ACTION INDUSTRIES INC. |
| Manufacturer Street | 25 HEYWOOD ROAD |
| Manufacturer City | ARDEN NC 28704 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 28704 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MEDICAL ACTION INDUSTRIES INC. |
| Generic Name | OR TOWEL |
| Product Code | PUI |
| Date Received | 2019-04-08 |
| Model Number | ORT400 |
| Catalog Number | ORT400 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JIANGSU GUANGDA MEDICAL MATERIAL GROUP CO., LTD. |
| Manufacturer Address | 18 BAOCHANG ROAD NORTH HAIAN JIANGSU, CHINA 226631 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-08 |