MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-26 for DERMACEA 441210 manufactured by Covidien.
[115397653]
Submit date: 7-26-2018. The incident sample has been requested but to date has not been received for evaluation. If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[115397654]
The customer reported fraying.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1282497-2018-00626 |
| MDR Report Key | 7724180 |
| Date Received | 2018-07-26 |
| Date of Report | 2018-10-02 |
| Date Mfgr Received | 2018-08-08 |
| Date Added to Maude | 2018-07-26 |
| 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 | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD,MA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DERMACEA |
| Generic Name | GAUZE/SPONGE,NONRESORBABLE FOR EXTERNAL USE |
| Product Code | NAB |
| Date Received | 2018-07-26 |
| Returned To Mfg | 2018-07-25 |
| Model Number | 441210 |
| Catalog Number | 441210 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD,MA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-26 |