MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2019-05-15 for NATURA 401553 manufactured by Convatec Dominican Republic Inc.
[145144035]
Initial reporter: (b)(6). Based on the available information, this event is deemed to be a serious injury. There is not enough information available in the case to confirm a pinhole or leak at the bottom of the pouch would cause a urinary tract infection. To date no additional information has been received. Should additional information become available, a follow-up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[145144036]
It was reported the device was hooked to a night drainage device and leaked during the night, soaking both the bed and the end user. The end user developed a urinary tract infection (uti) and was hospitalized for treatment. Urine testing was performed which confirmed the uti. Per the information provided both the end user and the physician feel the leakage caused or contributed to the uti. End user was placed on antibiotics (name unknown).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9618003-2019-03248 |
| MDR Report Key | 8612899 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2019-05-15 |
| Date Mfgr Received | 2019-06-03 |
| Date Added to Maude | 2019-05-15 |
| 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 | MS. JEANETTE JOHNSON |
| Manufacturer Street | 7900 TRIAD CENTER DRIVE SUITE 400 |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 3365424681 |
| Manufacturer G1 | CONVATEC DOMINICAN REPUBLIC INC |
| Manufacturer Street | KM 18.5 PARQUE INDUSTRIAL ITABO, S.A. HAINA |
| Manufacturer City | SAN CRISTOBAL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NATURA |
| Generic Name | BAG, URINARY, ILEOSTOMY |
| Product Code | EXH |
| Date Received | 2019-05-15 |
| Model Number | 401553 |
| Lot Number | 8J00138 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC DOMINICAN REPUBLIC INC |
| Manufacturer Address | KM 18.5 PARQUE INDUSTRIAL ITABO, S.A. HAINA SAN CRISTOBAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-15 |