MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-14 for DERMACEA 441603 manufactured by Covidien.
[86330350]
An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[86330651]
The initial reporter stated that the gauze is linting and unfolding.
Patient Sequence No: 1, Text Type: D, B5
[100530031]
An investigation of the reported condition was performed. The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the issue described by the customer. The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process. There is no sample or picture been received for evaluation. According to the investigation, the possible root cause would be the cutting blade moved during cutting process, so the gauzes was pulverized resulted loose contamination. The supplier has taken following actions: changed the swabs design of below gauze layer to increase width in first folding and below gauze must be use one side edge fold swabs to prevent lint contamination. Add cleaning process after cutting changed the slitting device and adopt automatic slitting machine that improve slitting accuracy to prevent sponges are flaking. So this complaint will be used for trending purpose. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183870-2017-00395 |
| MDR Report Key | 6865506 |
| Date Received | 2017-09-14 |
| Date of Report | 2018-02-12 |
| Date of Event | 2017-07-17 |
| Date Mfgr Received | 2017-07-19 |
| Date Added to Maude | 2017-09-14 |
| 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 02048 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02048 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DERMACEA |
| Generic Name | GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE |
| Product Code | NAB |
| Date Received | 2017-09-14 |
| Model Number | 441603 |
| Catalog Number | 441603 |
| Lot Number | 17092209 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-14 |