MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-01-10 for POSTOP KIT: NATURA DURAHESIVE MOLDABLE SKIN BARRIER 416932 manufactured by Convatec Inc..
[64433600]
Based on the available information, this event is deemed to be a reportable malfunction. A detailed investigation or batch review is not required at this time. If additional complaints occur with this batch and with the same malfunction code, these subsequent complaints shall be assessed against the batch criteria data. This issue will be monitored through the post market product monitoring review process. Additional patient/event details have been requested, but none have been provided to date. Should additional information become available a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[64433601]
Complaint reported by the end user that after wearing the device for 2-3 days she noticed purple discoloration encircling stoma circumferentially extending out about one-eighth of an inch. There are no openings in the skin, just discoloration. She states the only change in her routine is that she has a new caregiver who cuts the wafer instead of molding the opening. No further details have been provided.
Patient Sequence No: 1, Text Type: D, B5
[65940361]
A batch record review indicated no discrepancies related to the product quality or this complaint. Process checks and quality checks were performed with acceptable results. However, a non-conformance (nc) was noted for the mix product lot# (5c03629/1002208). Further investigation found this to be related to a documentation issue which has been resolved. The product quality was not affected by the nc and has been closed. No further investigation is required. This issue will be monitored through the post market product monitoring review process. 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 | 1049092-2017-10001 |
| MDR Report Key | 6239051 |
| Report Source | CONSUMER |
| Date Received | 2017-01-10 |
| Date of Report | 2015-12-07 |
| Date of Event | 2015-12-04 |
| Date Mfgr Received | 2017-01-18 |
| Device Manufacturer Date | 2015-05-19 |
| Date Added to Maude | 2017-01-10 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. JEANETTE JOHNSON |
| Manufacturer Street | 7900 TRIAD CENTER DRIVE SUITE 400 |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 3365424681 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POSTOP KIT: NATURA DURAHESIVE MOLDABLE SKIN BARRIER |
| Generic Name | BAG, DRAINAGE, WITH ADHESIVE, OSTOMY |
| Product Code | FON |
| Date Received | 2017-01-10 |
| Model Number | 416932 |
| Lot Number | 5E01787 |
| Operator | LAY USER/PATIENT |
| 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 AVENUE GREENSBORO NC 27409 US 27409 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-10 |