MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-02-10 for XEROFORM 1X8 OVERWRAP 200 CNT 8884431302 manufactured by Covidien.
[178376996]
The incident sample has been requested but to date has not been received for evaluation. If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Patient Sequence No: 1, Text Type: N, H10
[178376997]
The customer reported that she placed a piece of xeroform gauze over a superficial wound on her toe and covered it with a band aid. The band aid was saturated and when she removed the band aid, there was a full thickness burn after wearing shoes for 4 hours. Additional information provided by the customer stated that the injury is at the 2nd digit of her left toe. She did not consult a clinician when she first had the injury. She used bacitracin ointment and was doing self wound care. On (b)(6) 2020, the customer consulted a podiatrist and was prescribed santyl ointment. She used it for two days and it did not improve the wound. On (b)(6) 2020 an x-ray was done to the affected area. On the (b)(6) an mri was done and the customer was diagnosed with osteomyelitis. (b)(6) 2020 the customer was prescribed cefepime 1 gram iv twice a day for 45 days and is on the third day of treatment at home.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018120-2020-00402 |
| MDR Report Key | 9687313 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-02-10 |
| Date of Report | 2020-02-10 |
| Date of Event | 2019-12-22 |
| Date Mfgr Received | 2020-02-05 |
| Date Added to Maude | 2020-02-10 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | JILL SARAIVA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5086183640 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 1430 MARVIN GRIFFIN ROAD, PO B |
| Manufacturer City | AUGUSTA GA 30906 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30906 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XEROFORM 1X8 OVERWRAP 200 CNT |
| Generic Name | DRESSING, WOUND, DRUG |
| Product Code | FRO |
| Date Received | 2020-02-10 |
| Model Number | 8884431302 |
| Catalog Number | 8884431302 |
| Lot Number | 8010804 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 1430 MARVIN GRIFFIN ROAD, PO B AUGUSTA GA 30906 US 30906 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-10 |