MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-02-27 for CURITY 3968 manufactured by Covidien.
[68416402]
An investigation is currently under way; upon completion the results will be forwarded. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[68416403]
The customer reports we have a whole bunch of these gauze dressings where the product is sticking out of and part of the product is sealed in the seal. We had to open 4 or 5 today for one patient to get a sterile pack. Also, they are frayed on the edges and could leave part in the surgical site. No medical intervention required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018120-2017-05001 |
| MDR Report Key | 6361279 |
| Report Source | USER FACILITY |
| Date Received | 2017-02-27 |
| Date of Report | 2017-11-20 |
| Date of Event | 2017-02-02 |
| Date Mfgr Received | 2017-02-02 |
| Device Manufacturer Date | 2016-09-30 |
| Date Added to Maude | 2017-02-27 |
| 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 | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 1647 PERKINS RD |
| Manufacturer City | AUGUSTA GA 30913 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30913 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CURITY |
| Generic Name | FIBER, MEDICAL, ABSORBENT |
| Product Code | FRL |
| Date Received | 2017-02-27 |
| Model Number | 3968 |
| Catalog Number | 3968 |
| Lot Number | 16J227762 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 1647 PERKINS RD AUGUSTA GA 30913 US 30913 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-27 |