MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-11-03 for CONVEX SKIN BARRIER W/INTEGRATED FLOATING FLAN 14803 manufactured by Hollister Incorporated.
[21022300]
It was reported by the sister of the customer that the customer, had purchased a box of hollister convex skin barriers w/integrated floating flange, sku (b)(4). He stated that with the first two barriers form the box there was a plastic protrusion which was uncomfortable on the skin. With the third barrier that was applied, the customer reported that a plastic protrusion inside the barrier penetrated the skin causing it to bleed. The customer went to the hospital and wound closure strips were used to close the wounds which have since healed. No products are available for investigation.
Patient Sequence No: 1, Text Type: D, B5
[21236952]
No other events of this type were identified in the product performance system. The consumer stated they would provide additional information by mail but no contact information was received by hollister.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119193-2011-00012 |
| MDR Report Key | 2328961 |
| Report Source | 04 |
| Date Received | 2011-11-03 |
| Date of Report | 2011-11-03 |
| Date Mfgr Received | 2011-10-04 |
| Date Added to Maude | 2011-11-10 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Street | 2000 HOLLISTER DRIVE |
| Manufacturer City | LIBERTYVILLE IL 60048 |
| Manufacturer Country | US |
| Manufacturer Postal | 60048 |
| Manufacturer Phone | 8476805625 |
| Manufacturer G1 | HOLLISTER INCORPORATED |
| Manufacturer Street | 366 DARFT AVE |
| Manufacturer City | STURARTS DRAFT VA 24477999 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 24477 9998 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONVEX SKIN BARRIER W/INTEGRATED FLOATING FLAN |
| Generic Name | CONVEX SKIN BARRIER |
| Product Code | EZS |
| Date Received | 2011-11-03 |
| Catalog Number | 14803 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLLISTER INCORPORATED |
| Manufacturer Address | LIBERTYVILLE IL 60048 US 60048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-11-03 |