MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-28 for DUODERM CGF HYDROCOLLOID DRESSING STERILE 187662 manufactured by Convatec, Inc..
[23101037]
Based on the available info, this event is deemed to be a reportable malfunction. No additional pt/event details have been provided to date. Should additional info become available a follow-up report will be submitted. Three duoderm dressings were affected. A separate fda form 3500a will be submitted for each dressing involved.
Patient Sequence No: 1, Text Type: N, H10
[23101038]
It was reported that small holes were found within the dressing packing. No pt involvement was reported.
Patient Sequence No: 1, Text Type: D, B5
[32154647]
Additional information was received on november 10, 2015. The product associated with batch 4k03297, in this complaint investigation, was made according to specification. No previous investigations are available. After detailed batch review, no discrepancies (includes non-conformances/deviations) were found. It could not be determined based on photographs provided if there were small holes in product. Therefore there is not enough information to conclude the product did not meet specification and perform as intended. Product monitoring reviews will monitor for product trends if this issue were to reoccur. No further actions are required, and the complaint will be closed. No additional patient/event details have been provided to date. Should additional information become available a follow-up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1049092-2015-00436 |
| MDR Report Key | 4951716 |
| Date Received | 2015-07-28 |
| Date of Report | 2015-07-10 |
| Date Mfgr Received | 2015-11-10 |
| Device Manufacturer Date | 2014-11-06 |
| Date Added to Maude | 2015-07-30 |
| 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 | JEANETTE JOHNSON |
| Manufacturer Street | 7900 TRIAD CENTER DRIVE SUITE 400 |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 3362973009 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DUODERM CGF HYDROCOLLOID DRESSING STERILE |
| Generic Name | DRESSING, WOUND OCCLUSIVE |
| Product Code | MGP |
| Date Received | 2015-07-28 |
| Model Number | 187662 |
| Lot Number | 4K03297 |
| Device Expiration Date | 2019-10-31 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC, INC. |
| Manufacturer Address | 211 AMERICAN AVE. GREENSBORO NC 27409 US 27409 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-28 |