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.
[520804]
Reported by the complainant as follows: foreign material was found from patient's body. Sample will be sent to convatec headquarters for testing. Due to calculus found in both renal pelvis, pnl was conducted. Foreign material was found from right renal pelvis, when pnl was done. No adverse event was reported. Further detail will be added, when available.
Patient Sequence No: 1, Text Type: D, B5
[7795049]
Reports 2243969-2006-000023 & 2243969-2006-000024 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 | 2243969-2006-00023 |
| MDR Report Key | 777169 |
| 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 | 764949 |
| 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 |