MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2017-07-12 for XCM BIOLOGIC 30012-XX manufactured by Dsm Biomedical.
[79886644]
The device was not returned and no additional information was received. No lot number was provided, therefore no device history record review was performed.
Patient Sequence No: 1, Text Type: N, H10
[79886645]
It was reported that a patient received an xcm biologic device on the (b)(6) 2017. There is no demographic information about the patient available, nor is there any information about the type of procedure which was performed. It was discovered on the (b)(6) 2017 that there was a "rejection reaction after use on the patient". Additional information has been requested numerous times but no further information is available as of the date of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530154-2017-00003 |
| MDR Report Key | 6708273 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2017-07-12 |
| Date of Report | 2017-07-11 |
| Date of Event | 2017-06-07 |
| Date Mfgr Received | 2017-06-12 |
| Date Added to Maude | 2017-07-12 |
| 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 | MRS. ALICE COUSENS |
| Manufacturer Street | 735 PENNSYLVANIA |
| Manufacturer City | EXTON PA 19341 |
| Manufacturer Country | US |
| Manufacturer Postal | 19341 |
| Manufacturer Phone | 4847132165 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XCM BIOLOGIC |
| Generic Name | MESH, SURGICAL, COLLAGEN, PLASTIC AND RECONSTRUCTIVE SURGERY |
| Product Code | OXH |
| Date Received | 2017-07-12 |
| Model Number | 30012-XX |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DSM BIOMEDICAL |
| Manufacturer Address | 735 PENNSLYVANIA DRIVE EXTON PA 19341 US 19341 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-07-12 |