MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-03-25 for DUOLOCK TAIL CLSR CURVED TAN SRA8280 manufactured by Convatec Limited.
[41218119]
Expiration date: 05/2020. Manufacturing date: 05/2015. Based on the available information, this event is deemed a reportable malfunction. There were no reports of the patient being harmed as a result of this malfunction. No further information was available at the time of the report. Should additional information become available, a follow-up report will be submitted. Note: two cases associated with this complaint. A separate fda form 3500a has been completed for the unknown number of affected products with multiple possible lots numbers associated with this complaint. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[41218120]
It was reported by the end user that the tail clips dig and irritate her flesh in the area of the abdomen where the clip rests/digs in. It was also reported that this has occurred with other similar products for years.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000317571-2016-00031 |
| MDR Report Key | 5527245 |
| Report Source | CONSUMER |
| Date Received | 2016-03-25 |
| Date of Report | 2016-03-02 |
| Date Mfgr Received | 2016-03-02 |
| Date Added to Maude | 2016-03-25 |
| 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 | DUOLOCK TAIL CLSR CURVED TAN |
| Generic Name | APPLIANCE, COLOSTOMY, DISPOSABLE |
| Product Code | EZS |
| Date Received | 2016-03-25 |
| Model Number | SRA8280 |
| Lot Number | 5E03205 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC LIMITED |
| Manufacturer Address | FIRST AVENUE DEESIDE INDUSTRICAL PARK DEESIDE, FLINSHIRE CH52NU UK CH52NU |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-25 |