MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-11-03 for SUR-FIT AUTOLOCK DH FLEXIBLE SKIN BARRIER 401305 manufactured by Convatec.
[520940]
Reported by the complainant as follows: this is the re-occurrence of case 11504007: "a type of debris was discovered from the catheter of patient during operation. Although this patient rather tends to have calculus, this debris is not familiar to the doctor. " debris was found again from the same patient. Return sample will be shipped to manufacturer for testing, when available.
Patient Sequence No: 1, Text Type: D, B5
[7798597]
Reports 2243969-2006-000020, 2243969-2006-000021 & 2243969-2006-000022 refer to the same event. Convatec is not certain as to the identity of the debris found in this patient's catheter or if any untoward medical events arose as a result of it. This event is being reported as a due diligence measure while further case investigation and analysis continues on the debris samples expected to be sent to convatec.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243969-2006-00020 |
| MDR Report Key | 777193 |
| Report Source | 05 |
| Date Received | 2006-11-03 |
| Date of Report | 2006-10-05 |
| Date of Event | 2006-10-05 |
| Date Mfgr Received | 2006-10-05 |
| Date Added to Maude | 2006-11-07 |
| 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 | 0 |
| Manufacturer Contact | ADRIENNE MCNALLY |
| Manufacturer Street | 200 HEADQUARTERS PARK DRIVE |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9089042630 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUR-FIT AUTOLOCK DH FLEXIBLE SKIN BARRIER |
| Generic Name | OSTOMY WAFER |
| Product Code | EZR |
| Date Received | 2006-11-03 |
| Model Number | NA |
| Catalog Number | 401305 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 764973 |
| Manufacturer | CONVATEC |
| Manufacturer Address | 200 HEADQUARTERS PARK DR. SKILLMAN NJ 08558 US |
| Baseline Brand Name | SUR-FIT AUTOLOCK DH FLEXIBLE SKIN BARRIER |
| Baseline Generic Name | OSTOMY WAFER |
| Baseline Model No | NA |
| Baseline Catalog No | 401305 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-11-03 |