MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-02-21 for COLOHESIVE+ PCH CLD STD CLR 32MM(1X30)ES 401111 manufactured by Convatec Dominican Republic Inc.
[180337531]
Device 52 of 60. (b)(6). Based on the available information, this event is deemed to be a reportable malfunction. 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
[180337532]
It was reported that the starter hole was off-centered in wafers. The products were used. There was no harm reported and a photograph depicting the issue was received from the complainant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9618003-2020-02367 |
| MDR Report Key | 9737759 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2020-02-21 |
| Date Mfgr Received | 2020-01-27 |
| Date Added to Maude | 2020-02-21 |
| 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 | COLOHESIVE+ PCH CLD STD CLR 32MM(1X30)ES |
| Generic Name | POUCH, COLOSTOMY |
| Product Code | EZQ |
| Date Received | 2020-02-21 |
| Model Number | 401111 |
| Lot Number | 9A01580 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 | 2020-02-21 |