MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2007-05-05 for SKIN BOND CEMENT 400000 manufactured by Smith & Nephew Inc., Wound Management.
[769142]
Customer stated she uses skin-bond to hold her son's insulin pump in place, and the new skin-bond is not holding his pump on like the skin-bond with latex. The skin-bond with latex would allow changes to his infusion site three times per week. With the new bottle of skin-bond, they have been changing his site 1-2 times daily. She uses iv prep wipes first, uses skin-bond to paint a circle around the area where she will insert the cannula/pump, lets the skin bond dry 3-5 minutes, then inserts the cannula/pump. The cannula came out the last time her son's pump dislodge, but his blood sugar did not increase. His condition at this time is excellent. Outcome attributed to adverse event: cannula dislodged.
Patient Sequence No: 1, Text Type: D, B5
[8094122]
Evaluation summary: the lot record reviewed and had no anomalies or out of specification conditions during the production period affiliated with the customer's concerns. The lot met all inspection criteria upon receipt from the supplier of the adhesive material. Retain samples were visually examined, and the product was within specification. The product label contains the following information, "results may very depending on appliance used and skin condition. For best results apply very thin layer on dry skin. " when customer reported this event, customer was told not to use skin-bond on the insulin pump. This product is no longer manufactured or sold by smith & nephew effective february, 2007. No further action will be taken at this time. However, we will continue to monitor for this type of event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017593-2007-00004 |
| MDR Report Key | 966072 |
| Report Source | 04 |
| Date Received | 2007-05-05 |
| Date of Report | 2007-04-05 |
| Date of Event | 2007-04-05 |
| Date Mfgr Received | 2007-04-05 |
| Device Manufacturer Date | 2006-07-01 |
| Date Added to Maude | 2007-12-19 |
| 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 | JIM IRVIN |
| Manufacturer Street | 11775 STARKEY RD |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273921261 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKIN BOND CEMENT |
| Generic Name | STOMAL APPLIANCE CEMENT |
| Product Code | EZR |
| Date Received | 2007-05-05 |
| Model Number | 400000 |
| Catalog Number | 400000 |
| Lot Number | 511934 |
| ID Number | * |
| Device Expiration Date | 2008-02-28 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 935600 |
| Manufacturer | SMITH & NEPHEW INC., WOUND MANAGEMENT |
| Manufacturer Address | * LARGO FL * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-05-05 |