MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2002-01-31 for DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM 7025 manufactured by Johnson & Johnson Medical (sherman).
[239273]
It was reported that device layer two wrap exhibited too much tension in use. An unspecified number of patients involved in the facility's clinical trial may have developed some compromise of the skin due to excessive tension. One hundred and fifty patients were involved in the trial but the exact number affected has not been determined. Reportedly, the epidermal layer of the skin may have broken down and sloughed off in distinct areas. In some instances, a central necrosis of the venous ulcer was noted. These conditions only required topical, palliative treatment. Patients had reported feeling tightness and discomfort after application of the device. The investigator reports that these symptoms suggest compromise of capillary circulation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2002-00068 |
| MDR Report Key | 374850 |
| Report Source | 06 |
| Date Received | 2002-01-31 |
| Date of Report | 2002-01-07 |
| Date Facility Aware | 2001-09-24 |
| Report Date | 2002-01-07 |
| Date Mfgr Received | 2002-01-07 |
| Device Manufacturer Date | 2001-07-01 |
| Date Added to Maude | 2002-02-04 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. RITA MCINTYRE |
| Manufacturer Street | ROUTE 22 WEST P.O. BOX 151 |
| Manufacturer City | SOMERVILLE NJ 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal | 088760151 |
| Manufacturer Phone | 9082182398 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM |
| Generic Name | KIT, WOUND DRESSING |
| Product Code | MCY |
| Date Received | 2002-01-31 |
| Model Number | NA |
| Catalog Number | 7025 |
| Lot Number | 2001-07 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 02 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 363978 |
| Manufacturer | JOHNSON & JOHNSON MEDICAL (SHERMAN) |
| Manufacturer Address | HIGHWAY 75 & 1417 SHERMAN TX * US |
| Baseline Brand Name | DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM |
| Baseline Generic Name | KIT, WOUND DRESSING |
| Baseline Model No | NA |
| Baseline Catalog No | 7025 |
| Baseline ID | NA |
| Baseline Device Family | ADVANCED WOUND CARE |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 48 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K970721 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-01-31 |